PPP-Botnia Exercise Intervention Study

Study Overview
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Brief Summary
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The aim of the study is to evaluate the long-term effects of a prescription of exercise versus a group-based training program on aerobic fitness, muscle strength and metabolic variables in subjects with poor physical fitness. The participants are further stratified for a family-history of type 2 diabetes. The number of subjects in each group of intervention is planned to be 150, aged 30-70 years and non-diabetic. Intervention: All study subjects take part in two individual sessions for exercise prescription aiming at moderate exercise of 30 minutes at least 5 days a week. The prescription group perform exercise by themselves, while the training group will be offered supervised physical training, including both endurance training and training in gym twice a week during 12 months. The subjects will be followed up at 1, 2, 3 and 5 years after the basal visit. Methods of follow-up: At the study visits physical fitness will be measured by a 2 km walking test, glucose tolerance by oral glucose tolerance test with measurement of glucose and insulin. Lipids will be measured. Questionnaires will be used to follow lifestyle, physical activity, cardiovascular disease and medication. In the training group 30 subjects with and 30 subjects without a family history of type 2 diabetes will participate in a sub-study including muscle- and fat-biopsy before the start of the study, after 1 and 5 years.

Official Title
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PPP-Botnia Exercise Intervention Study

Conditions
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Family History of Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: poor physical fitness based on repeated walking test (UKK 2 km walking test) non-diabetic Exclusion Criteria: health problems complicating moderate physical training

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Training group<br>The training group received individualized information about moderate training and was also offered training in group twice a week during 12 months. The training included both endurance training (nordic walking, water gymnastics) and training in gym. | Behavioral: Physical activity<br> <br> |
| Active Comparator: Prescription of exercise<br>Individualized sessions for exercise prescription aiming at moderate exercise of 30 minutes at least 5 days a week | Behavioral: Physical activity<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in physical fitness | Fitness will be measured by a 2 km walking test, which is an indirect measure of oxygen uptake | will be measured at 1, 2,3 and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in body composition | body composition will be measured as weight, waist, fat percentage | measured at 1, 2, 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prescription of exercise, Physical fitness, Family history of type 2 diabetes