PPP-Botnia Exercise Intervention Study

May 5, 2014 updated by: Folkhälsan Researech Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Folkhälsan Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Training group
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
Active Comparator: Prescription of exercise
Individualized sessions for exercise prescription aiming at moderate exercise of 30 minutes at least 5 days a week
Behavioral: Physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement in physical fitness
Time Frame: 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
will be measured at 1, 2,3 and 5 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in muscle strength
Time Frame: will be measured before study and after 1 and 5 years
muscle strength will be followed by the method of one repetition maximum
will be measured before study and after 1 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Folkhälsan Researech Center

Collaborators

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

Investigators

  • Principal Investigator: Bo Isomaa, MD, Folkhälsan Research Center, Helsinki, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

May 4, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPP2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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