PPP-Botnia Exercise Intervention Study

Not Applicable

Completed

• Conditions: Family History of Type 2 Diabetes

• Registration Number: NCT02131701
• Lead Sponsor: Folkhälsan Researech Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2008-08
• Study Completion: 2013-08
• Status Verified: 2014-05
• Study First Submitted: 2014-05-04
• Study First Submitted QC: 2014-05-05
• Last Update Submitted: 2014-05-05
• Study First Posted: 2014-05-06
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
improvement in physical fitness	will be measured at 1, 2,3 and 5 years	Fitness will be measured by a 2 km walking test, which is an indirect measure of oxygen uptake

Secondary Outcome Measures

Name	Time	Method
changes in body composition	measured at 1, 2, 3 and 5 years	body composition will be measured as weight, waist, fat percentage

Trial Locations

Locations (1)

Folkhälsan Research Center; 🇫🇮 Helsinki, Finland