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PPP-Botnia Exercise Intervention Study

NCT02131701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2014-05-06

No results posted yet for this study

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.

Conditions

  • Family History of Type 2 Diabetes

Interventions

BEHAVIORAL

Physical activity

Sponsors & Collaborators

  • Närpes Health Care Center, Närpes, Finland

    collaborator UNKNOWN

  • Department of Social Services and Health Care, Jakobstad, Finland

    collaborator UNKNOWN

  • Department of Clinical Sciences, Lund University Diabetes Center, CRC, Lund University, Malmö, Sweden

    collaborator UNKNOWN

  • Folkhälsan Researech Center

    lead OTHER

Principal Investigators

  • Bo Isomaa, MD · Folkhälsan Research Center, Helsinki, Finland

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-08-31
Completion
2013-08-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02131701 on ClinicalTrials.gov