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Completed

NCT Number: NCT02131701

PPP-Botnia Exercise Intervention Study

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Folkhälsan Research Center

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

Primary outcomes

  1. 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

Secondary outcomes

  1. changes in body composition

    Time frame: measured at 1, 2, 3 and 5 years

    body composition will be measured as weight, waist, fat percentage

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Folkhälsan Researech Center

Other

Collaborators

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

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2013
First posted
May 6, 2014
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.