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PPP-Botnia Exercise Intervention Study

PPP-Botnia Exercise Intervention Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02131701
Enrollment
290
Registered
2014-05-06
Start date
2006-10-31
Completion date
2013-08-31
Last updated
2014-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Family History of Type 2 Diabetes

Keywords

Physical fitness, Family history of type 2 diabetes, Prescription of exercise

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.

Interventions

BEHAVIORALPhysical activity

Sponsors

Närpes Health Care Center, Närpes, Finland
CollaboratorUNKNOWN
Department of Social Services and Health Care, Jakobstad, Finland
CollaboratorUNKNOWN
Department of Clinical Sciences, Lund University Diabetes Center, CRC, Lund University, Malmö, Sweden
CollaboratorUNKNOWN
Folkhälsan Researech Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
improvement in physical fitnesswill be measured at 1, 2,3 and 5 yearsFitness will be measured by a 2 km walking test, which is an indirect measure of oxygen uptake

Secondary

MeasureTime frameDescription
changes in body compositionmeasured at 1, 2, 3 and 5 yearsbody composition will be measured as weight, waist, fat percentage

Other

MeasureTime frameDescription
changes in muscle strengthwill be measured before study and after 1 and 5 yearsmuscle strength will be followed by the method of one repetition maximum

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026