Intervention Study - Effectiveness of Smartphone Delivered Interval Walking Training to Patients With Type 2 Diabetes
Intervention Study - Effectiveness of Smartphone Delivered Interval Walking Training to Patients With Type 2 Diabetes
Type 2 Diabetes (T2D) is one of the most common chronic diseases world vide. Patients with
 T2D experiences reduced quality of life and have a lower physical activity level. Physical
 activity is well documented treatment to the patient group. The effect of physical activity
 is shown to reduce co-morbidity, and better functional level and quality of life.

 Interval Walking Training (IWT) is a new and effective exercise type. IWT is done by walking
 in a slow and a fast tempo. InterWalk is an application to a smartphone. By using InterWalk
 the patient can to IWT independently and when used, the app has, as an exercise tool, the
 potential to better the individual functional level and to measure the physical activity
 level with the integrated personalised walking test.

 Motivation for change of habits and lifestyle is subjectively determined by the individual,
 his or hers individual resources and environment. It is important to get insight in these
 individual challenges in order to be better structure possible help.

 The combination of an exercise log, a measure of physical activity fromInterWalk and insight
 in motivational aspects on an individual level, is essential for successful individualised
 training.

 The primary objective of the study is to investigate if the InterWalk app is more effective
 in increasing the physical activity level compared to a standard care offer in a sample of
 newly T2D diabetes patients across 52 weeks.

 Secondarily, we will investigate if the IW app can reduce sitting time, induce weight loss,
 improve glycaemic control, increase quality of life, improve cardio-respiratory fitness and
 reduce the use of diabetes medication.

 The study is designed to test the hypothesis that replacing a standard exercise program in
 the normal municipal standard care with the Interval Walking Training delivered by the IW app
 with and without a motivational support program, can increase the long-term physical activity
 level in patients with T2D for a period of 52 weeks.

 From January 2015 to June 2016 all patient's with T2D, who are referred to the promotion
 centres in the municipality, will be offered to participate in the study. In total 513
 patients with T2D from different municipalities in Denmark will be included and randomly
 allocated into three groups. One group will receive standard care and the two other groups
 will do IWT with the InterWalk app. All three groups are followed by the promotion centre for
 8-14 weeks (according to the rehabilitation in the municipality) and hereafter only one of
 the IWT groups will receive motivational support up to 52 weeks.

 All patients, no mater group allocation, will be tested and fulfill questionnaires, three
 times during the intervention period - at baseline, after 8-14 weeks and after 52 weeks. The
 interventions take place at the promotion centres in the municipalities two times a week and
 the patient will be encouraged train by them selves one time a week.
Background Type 2 diabetes (T2D) is one of the most common long-term medical conditions
 worldwide. The patients have a two-fold increased mortality rate compared to the general
 population T2D is a major problem in Denmark and the incidence is estimated to rise from
 280.000 today to approximately 500.000 people by 2020 (5).

 The T2D rehabilitation program in the Danish municipalities has the overall purpose of
 introducing and helping patients to a healthier lifestyle (6). The program is conducted in a
 period of 8-14 week with some or no exercise intervention, with no long-term follow-up. Not
 much is known on the amount and integration of PA in the patient's everyday life following
 the intervention (7). This major variation across municipalities poses a problem in the
 rehabilitation of TD2, as the quality of rehabilitation depends on the geographical location
 of the T2D patient.

 Several studies have shown that supervised PA is advantageous; in patients with T2D on key
 metabolic factors (6-9) and that it improves quality of life and reduces the risk of
 all-cause mortality (1,2,6,10,11,12). Due to the many beneficial effects of PA on T2D
 patients, PA is an important factor in the prevention and treatment of T2D (13). Long-term PA
 interventions have employed supervised exercise regimes (14,15) that are effective, but also
 demanding and expensive. Attempts to increase the daily physical activity level on a large
 scale, in a free-living "real life", have very little effect (14-16) despite well-established
 patient education programs. In general, the exercise adherence is low and dropout rates are
 high in this group of patients. A large number of patients with T2D experience diminished
 quality of life, decreased physical functioning, diminished exercise tolerance (17), numerous
 patients are unmotivated or incapable to change behaviour and the prevalence of depressive
 and anxiety symptoms are highly prevalent in T2D patients (17,18,19). Collectively this could
 pose important barriers to engagement in exercise and reaching the recommended level of PA
 (20).

 Karstoft et al (2013) examined the feasibility of implementing a free-living interval walking
 (IWT) and continuous walking training program in a smaller sample of patients with T2D. IWT
 was initiated and monitored by a Japanese training device, the JD-mate (10). The study found
 remarkable effects on physical fitness level, body composition and glycaemic control and with
 a compliance rate of more than 85% and a very low dropout level (9). Based on the experiences
 by Karstoft et al and several pilot testing's in the Danish Diabetes Association (DF), we
 believe that IWT can be an approach to handle lack of PA in patients with T2D. However the
 JD-mate, is expensive (3500 kr.), Japanese instructions, lacks automatic transmission of data
 and is thus not user-friendly on a larger scale. It is evident that novel low cost, more
 sustainable exercise solutions and suitable vehicle are needed and through this, improve
 quality of life and increase life expectancy in these patients.

 The use of Tele-Health interventions (THI) have the potential to educate and engage patients
 with T2D in self-management in the long-term and the evidence suggests that THI could be
 effective and feasible in improving clinical outcomes in diabetes care (14,15,22,23). The
 widespread and increasing use of smartphone applications is opening new ways to improve
 health and health care delivery. It might be ideal to use THI to increase physical activity
 and hereby target a large part of the population by simple and inexpensive means. The
 smartphone has been used as a tool among others to register exercise, diet, weight and plasma
 glucose levels, but the evidence of using a smartphone as an exercise device is lacking (24).

 In 2010 the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) and TrygFondens
 Centre for Aktiv Sundhed (CFAS), Rigshospitalet, Denmark, developed the InterWalk Application
 (IW app) to the smartphone to promote IWT on a larger scale. IWT has the potential to
 increase physical activity in a large group of T2D patients and hopefully improve lifestyle
 in patients with T2D. However, motivation for lifestyle changes is subjectively driven and
 individually determined (25-27). The personal resources and the close environment are key
 determinants of how challenges are handled in everyday life (28,29). Motivational factors are
 important for changing physical activity behaviour in patients with T2D, but knowledge on how
 motivation is maintained for a sustainable active lifestyle is limited. Studies of the
 effectiveness of employing smartphones as a vehicle to improve physical activity behaviour in
 everyday life in the long-term in patients with T2D is therefore needed.

 Aim/purpose - (Hypothesis) The primary objective of the study is to investigate if the
 InterWalk app is more effective in increasing the moderate-and-vigorous physical activity
 level compared to a standard care offer in a sample of T2D patients across 52 weeks.

 Secondarily, we will investigate to what extend the IW app can reduce sitting time, induce
 weight loss, improve glycaemic control, increase quality of life, improve cardio-respiratory
 fitness and reduce the use of diabetes medication.

 The primary hypothesis is to test the hypothesis, that replacing a standard exercise program
 in the normal municipal standard care with the Interval Walking Training delivered by the IW
 app, the patient will become more physical active. The secondary and explorative hypothesis
 is that motivational support will increase the individual long-term physical activity level
 in everyday in patients with T2D.

 Methods Study design The study is a 52-weeks single-blinded pragmatic randomized controlled
 trial, where the participants are allocated into three arms. Two of the arms will receive IWT
 with or without additional support. The control arm will receive the standard care. The
 interventions are delivered by the Danish municipalities. A detailed description of the three
 arms is found below. The study is carried out in a subgroup of the DD2 cohort.

 Participants, Recruitment and eligibility All patients referred to the promotion centre in
 the municipalities from January 2015 will be screened for eligibility. The patients will be
 informed about the study and will be given formalized oral and written material, a consent
 form and a free post envelope. Upon reception of the consent form by the health professional
 at the municipality, the patient will be contacted by one of the health professionals
 assigned to the study and a date for the first visit is arranged.

 Enrolment is anticipated to take approximately 18 month and begins in January 2015, and is
 expected to be completed in July 2017. The intervention will take place at the promotion
 centres in municipalities in Denmark.

 Sample size considerations The minimum difference of interest (MDI) is 10 minutes per day.
 After applying Bonferroni adjustment due to multiple comparisons in the three group trial and
 shared end-points, a total of 393 participants are needed using an sample SD of 25 minutes
 per day (30) with an α of 0.017 (two-tailed) to obtain a statistical power (1-β) of 80%.
 Allowing for an attrition rate of 30%, 513 patients (171 in each group) are allocated in the
 three arms.

 Allocation, randomization and concealment Patients are randomized using random permuted
 blocks (2x2x2) and stratified by gender to ensure an equal number of participants in all
 groups across the allocation period. The allocation sequence is generated through a
 standardized computer program by an independent researcher not affiliated to the study and is
 concealed until the study arms are assigned. Randomization of each patient to one of the
 three groups in the study is done after the baseline tests have been conducted by the health
 professionals at the promotion centres. The scientific staff is blinded to the allocation.
 The health professionals at the promotion centre are not blinded to allocation according to
 control group (1/3) or intervention groups (1/3: IWT and 1/3: IWTsupport). After the
 intervention period at the promotion centre, the allocation to either control, IWT or
 IWTsupport is unsealed to the patients and the health professionals at the promotion centres.
 The scientific staff is still blinded.

 Interventions Group 1 (control group): Patients in this group will receive the standard
 rehabilitation program with the overall purpose of lifestyle changing in T2D patients in a
 multimodal setting in the municipality including physical activity. In addition to exercise,
 the rehabilitation consists of education, smoking cessation and dietary change with the
 purpose of weight loss, motivation groups and self-care. The duration of the rehabilitation
 differs between municipalities with duration from 8 to 14 weeks. There will be no follow-up
 from the municipality, which is the normal procedure in the municipality.

 Group 2 (IWT with without motivational support after 8-14 weeks): Patients in this group will
 be engaged to IWT with the IW app (see: The InterWalk Application). The intervention period
 will follow the period in which the rehabilitation program is carried out in the municipality
 (duration from 8-14 weeks). The patients are encouraged to perform IWT three times per week,
 60 minutes per session. The municipality offers to walk with the patient´s two times per week
 for 60 minutes per session in group sessions with additional 30 minutes of group discussion
 afterwards. The last and third time the patients have to walk by themselves for 60 minutes
 per session. The participating patients will receive a thorough introduction to the IW app
 and follow-up during the intervention (8-14 weeks) from the health professionals. At the end
 of the intervention period, the health professionals, conducts a transition program,
 preparing the patients to continue IWT with IW app on their own. There will be no follow-up
 from the municipality, which is the normal procedure in the municipality.

 Group 3 (IWTsuppport) IWT with motivational support after 8-14 weeks: Patients in this group
 will like patient´s in intervention group 2 be engaged to IWT with the IW app. The
 intervention period will be 52 weeks. The first 8-14 weeks will be conducted together with
 group 2 with a thorough introduction to the IW app and IWT three times per week for 60
 minutes. In addition to the IWT from week 0 to 52, the patients in this group will receive
 motivational support from week 8-14 to week 52 by the health professionals at the promotion
 centre (see below for information regarding the IW app and the motivational support part).

 The InterWalk Application The IW App is a personal trainer as well as a monitor unit, which
 allows continuous and automatic transmission of physical activity data to a central data base
 in DD2. The IW app guides the user in IWT with repeated cycles of 3 minutes fast and slow
 walking. During IWT the app provides the patients with continuous feedback on the walking
 intensity (10). The feedback is personalized through a standardized eight-minute walking
 test, performed before engaging in IWT. The patients are able to track exercise history and
 receive historic feedback on the quality of the IWT sessions. The feedback system employs the
 on-board accelerometer and GPS system to assess intensity and geographical location.

 The patients are obligated to enter their social security (CPR) number before using the app.
 Uniquely, this will allow the scientific teams to integrate the app into the health care
 system, link the data with the Danish disease and demographic registers and thus, will enable
 the study of long term nation-wide effects of IWT in T2D rehabilitation.

 The application has been through extensive piloting in different groups of patients with T2D.
 Information on training intensity, total number of steps per day and IWT-data and data from
 the standardized walking test is stored on the smartphone or IPod and automatically
 transmitted to a central database when connected to Wi-Fi or mobile data network.

 Individual motivation (IWTsupport) Motivational support will in addition to the IWT be
 offered in intervention group 2 after the intervention at the promotion centre. The support
 is initiated and conducted by the health professionals at the promotion centres.

 -  SMS-track: The patient i intervention group 2 will receive motivational support which
 consists of Short Message Service -Track (SMS-Track), phone calls, goal setting and i
 motivational interviews (see below). The different parts of the motivation intervention
 will be handled and executed by the health professionals at the promotion centres in the
 municipalities.

 -  Short Message Service - Track: The first Sunday after enrolment a SMS-track is send to
 all patients in either group 2 or 3. The patients will be asked to confirm that they are
 part of the study, before the next SMS regarding their IWT is send. The patient can
 receive up to 3 SMS's regarding IWT depending on their answers.

 -  Phone calls: The patient's answers to the SMS-track, constitute whether a personal phone
 call from a health professional if necessary. The aim of the call is to help and support
 the patient in continuing to keep doing IWT with IW app. Questions from the health
 professionals addresses how the patient is doing in general, why the patient has
 answered that they haven't been doing IWT the past week, questions regarding how to help
 the patient doing IWT, or questions about the IW app. The patient will have time to ask
 questions of concern to the health professional.

 -  Standardized walking test: Every 4th week a SMS will be send to the patient regarding
 new goal setting.

 Individual goal setting: To measure the patients motivation for physical activity using the
 IW app in group 2 and 3, we ask the patients to set individual goals every 4th week, related
 to their everyday life, during the intervention period (group 2 (4-18 weeks) and group 3
 (0-52 weeks) (40) - The goal setting is based on the S.M.A.R.T.-principle where S stands for
 Specific, M for Measurable, A for achievable , R for relevant and T for timely (41).

 - IWTsupport group sessions: Patients in group 3 have the opportunity to participate in IWT
 with other patient and a InterWalk ambassador at the municipality once a week after the
 intervention at the promotion centre.

 Motivational interviews: Four motivational interviews will be scheduled for patients in group
 2, in the period where the patient no longer is part of the formalised IWT in the
 municipality (week 12-52). The aim of these interviews is to help he patients to maintain
 motivation and focus tin prioritizing IWT in their everyday life. The interview will take
 place at the promotion centre.

 Measurements

 -  Level of daily physical activity To evaluate the level of moderate-to-vigorous-intensity
 physical activity all participants will be equipped with an accelerometer (Axivity AX3,
 Newcastle, UK) for 10 consecutive days, 3 times during the intervention period - at
 baseline and after 4-18 weeks and 52 weeks after enrolment. One accelerometer will be
 placed with patch (Leukomed T, BSN medical, Germany) on the lateral side of the right
 thigh and one accelerometer on the lumbar spine. The patients will be instructed not to
 remove the accelerometer during the three periods. The accelerometers can be worn when
 taking a shower, swimming etc.

 -  Smart-phone administered standardized walking test The walking test in the IW app
 consists of 5 stages; 1) 30 sec. of standing still, 2) 2 min. of slow walking 3) 2 min.
 of walking at moderate intensity 4) 2 min. walking at high intensity 5) 1 min. walking
 at highest intensity possible. The four later paces are self-selected. The test is
 performed with the Smartphone placed at a pocked at the hip and the instructions are
 communicated auditory through earphones. To ensure the right walking intensity in the
 intervention period, the patients are asked to perform the test every 4th week.

 -  Sit-to-Stand Test The test measures the lower body strength and will be administrated
 using a chair without arms, with a seat height of 43 cm. The patient is encouraged to
 complete as many full stands as possible within a 30-sec time limit (32).

 Electronic log of data from IWT to the central database Adherence to the intervention is
 determined by an evaluation of the electronic log of data from IW app to a central database.
 All the uploaded data can be quantified into adherence.

 -  Physical Activity Questionnaire "The Resent Physical Activity Questionnaire" (RPAQ) is a
 self-rated physical activity questionnaire. The RPAQ has 9 main questions which covers 4
 domains of physical activity: domestic life, work, recreation and transport. Physical
 Activity is estimated in MET (Metabolic Equivalent) (35).

 -  Short Form -12 (SF-12) The SF-12 was developed as a short form of the 36-item Short-Form
 Health Survey (SF-36). The questionnaire consists of 12 questions and uses a Likert
 scale of 1 to 3 for the physical function items; 1 to 5 for the bodily pain, social
 function, and general health perceptions items; 1 to 6 for the vitality and mental
 health; and a dichotomous scale of yes/no for the presence of role function limitations.
 The higher score, the higher level of health or functioning (34).

 -  Behavioural exercise regulation questionnaire (BREQ-2) Behavioural exercise regulation
 questionnaire (BREQ-2) measures individual motivation for physical activity. The
 Questionnaire consists of 19 questions in a 0-4 Likert format.

 -  Questions on motivation for physical activity for patients with Type 2 Diabetes All
 patients will be asked to answer four questions in a 0-4 Likert format, regarding their
 habits for doing physical activity after being diagnosed with T2D.

 -  Personality Questionnaires The patient will be asked to complete two questionnaire
 regarding personality, the NEO-Five Factor Inventory (NEO-FFI) and a Sensation Seeking
 Scale (SES).

 The NEO-FFI consists of 60 questions in a 0-4 Likert format constructed by selecting 2 items
 from each of the six facets characterizing each of the five personality traits (Neuroticism,
 Extraversion, Openness, Agreeableness, Conscientiousness) assessed by NEO-PI-R (36).

 The Sensation Seeking Scale is a 40 items self-administered questionnaire and consists of 40
 questions designed to test the tendency towards varied, novel and intense sensations (37).
 The SES-questionnaire is in its design impertinent as it consists of only two possible
 response options for each question. The patient will be encouraged to answer the questions,
 but is not required an answer.

 We do not know much about what characterizes the individual to either participate or to
 decline an intervention e.g. diet, smoking cessation or physical activity. The two
 personality questionnaires are part of the project because it is essential to get more
 knowledge on personality traits, risk behavior and adherence to an intervention in this case
 physical activity. By this knowledge it will be possible to better individualize the
 intervention and by this hopefully get a higher adherence in the long term.

 -  Monitoring of body temperature To detect possible effects of exercise on mitochondrial
 function a measure of body temperature with an ear thermometer will be performed. Time
 of measure, season and weather conditions, diseases within the last week and meals
 before the measure will be noted.

 -  Demographic and social economic Information: Information on demographic will be obtained
 using standard procedures (height, weight, waist and hip circumference). The demographic
 data will be obtained from the patient's journal at the Promotion Centre. A tape measure
 and a weight will be provided to each promotion centre to ensure standardization among
 health professionals.

 -  Relevant national registers will be used for information regarding co-morbidities,
 medical history and use of medicine. All the information from the patient's journal and
 from relevant registers will be used when all data, from all patients, are collected.
 The data will be protected by the "Lov om behandling af personlige oplysninger" (see
 'Protection of personal information', page 12).

 -  Metabolic markers The patients are encouraged to maintain the recommended regular visits
 every 3th month at the general practitioner (GP) in the intervention period (52 weeks).
 Results from the visits including the blood sample are collected from the national
 database DSAM.

 Risk, side effects, and discomfort General considerations The exercise intervention (Interval
 Walking Training) is expected as a minimum to be as effective as the standard care programme
 currently offered to patients with T2D at the municipality. Interval walking Training with
 the use of a Tele-Health solution is providing patients with T2D with a feasible option on
 how to implement and maintain a physical active lifestyle in a gentle and flexible way. The
 intervention is expected to result in remarkably health benefits on a long-term basis in
 terms of improved increased VO2max, blood glucose regulation, and quality of life and
 motivation for a more active everyday life.

 The study is important and will contribute to great knowledge about how to implement and thus
 increase public health in a large and growing cohort of patient´s with T2D.

 Measurements Smartphone administered walking test: The patients are expected to reach 80-85%
 of VO2max during the IW walking test. This will cause some degree of breathlessness.

 AX3 Axivity accelerometers: Due to the patched by which the accelerometers are hold on the
 thigh and lower bag, itching and redness may occur in allergic subjects. In those cases the
 subjects are encouraged to remove the patches immediately and if necessary consult a general
 practitioner. The patients will be informed on procedures in writing containing pictures of
 the application of accelerometers and possible discomfort.

 Interval walking training: The IWT will cause some degree of breathlessness in the fast
 walking interval periods.

 Anthropometric measurements, sit-to-stand test, temperature, questionnaires and motivational
 initiatives: These methods are not associated with any known risk or other unpleasant.

 Statistical analysis All analyses will be conducted according to the Intention-to-treat
 principle. Mixed model analyses will be employed to determine the group X treatment effects
 of the intervention across twelve months. The secondary outcomes will be analyzed using the
 same approach. Assuming that the data on potential drop-outs are missing at random multiple
 imputation procedures will employed to handle missing data. Patterns of missing data will be
 investigated. Per protocol analyses will be performed to support the primary analysis.

 Ethical considerations The study is expected to result in limited risks, adverse effects and
 discomfort to the patients. No invasive methods will be used besides blood samples taken by
 the GP at regular visits. The patients will benefit from the study in terms of enhanced
 physical capacity and by introduction to effective training methods.

 The randomization of the participating patients into three groups is necessary to evaluate
 the effectiveness of the InterWalk app. The intervention groups (group 2 and 3) are alike as
 long as the standard rehabilitation with physical activity proceeds in the municipality. From
 hereafter only group 3 will be supervised and will receive motivational support from the
 health professionals. This differentiation between groups is needed in order to obtain
 insight regarding motivational factors of importance to the individual, to maintain a
 physical active everyday life.

 The two personality questionnaires in the study will help to get insight on personality,
 physical activity and motivation for behavioural changes (e.g. more physical active everyday
 life). With this knowledge, the results from the study can help the health professionals at
 the promotion centres, to better allocate patients with T2D, into a rehabilitation offer
 adjusted to the individual and not as a standard offer in the municipality.

 Expected outcomes Performing IWT might be a suitable and effective way to exercise for at
 large group of patients with T2D. The patient can walk everywhere and IWT can hereby be
 integrated and maintained in the patient's everyday life. Experiences from the study can be
 used in planning interventions with the IW app and IWT, to patients with other lifestyle
 diseases e.g. Constructive Obstructive Pulmonary Lung Disease (COPD) and Heart Diseases. The
 aim is to obtain lifelong physical activity for the individual in their everyday life.

 Patient insurance The intervention takes place at the promotion centres in the Municipality
 and the patient is, if anything should happen during the intervention period, insured by
 'Patient Forsikringen'. The law says '…personer, der deltager i biomedicinske forsøg m.v.,
 der udføres af private firmaer, foreninger m.v. er omfattet af lovens område, hvis forsøget
 udføres under direkte ansvar af et sygehus, en statslig højere uddannelsesinstitution m.fl.'.
 The University of Copenhagen is the 'statslige højere uddannelsesinstitution in this study.

 Protection of personal information All personal information on the patient's identities are
 protected by the "Lov om behandling af personlige oplysninger". A unique subject ID number
 will be subscribed to all patients in order to anonymize data. The identification key (ID to
 personal information) will be encrypted and stored securely and separately from the unique ID
 number on a secure database. In this way no information on patient´s can be assigned to the
 ID number. All data is automatically backed up on a secure server. Questionnaires is
 completed online and automatically uploaded with the ID number to the secure data base.

 Each promotion centre will be assigned with secured logons to the database and only the
 health professional assigned to the study, will get logons and will only be able to see the
 patients included in the study at their promotional centre. The scientific members have
 access to the secure database and data from all the included patients. All data will be
 secured in the database and a bag up of all the data is stored in an extern hard disk which
 is also secured. It is possible to track all logons to the database as well as all tasks done
 in the database.

 To enter the IW app the patients are obligated to enter their CPR number, which immediately
 are encrypted to protect against inappropriate use of the number from unauthorised people not
 connected to the study. The health professionals in the municipalities will be educated in
 data entry and will only have access to their own promotion centre. Only the research team
 will have access to data processing.

 The IW app is already approved by "Datatilsynet" (2008-58-0035 (paraplygodkendelse i Region
 Syddanmark)) and the RCT-study will in addition be reported to "Datatilsynet".

 Compensation There will be no compensation given to the patient. All participating patients
 are treated in accordance with the national guidelines regarding rehabilitation in the
 municipality.

 Dissemination The data will be published in international peer-reviewed journals. The results
 are to be reported according to the CONSORT guidelines (38). All results will be disseminated
 (negative, positive and inconclusive findings). All result will be published (positive,
 negative and inconclusive).

 For references - see the section 'References'
Inclusion Criteria:

 -  Patients are eligible if they are diagnosed with T2D and are more than 18 years of
 age.

 Exclusion Criteria:

 -  Medical contraindications to exercise e.g. if the patient has developed chronic
 complications in the locomotive apparatus, e.g. painful osteoarthritis or heart
 conditions (30,39) and already is participating in other studies at the promotion
 centres concerning PA.