PPP-Botnia Exercise Intervention Study

NCT02131701 | Completed

• 1 other identifier: PPP2007
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Family History of Type 2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• improvement in physical fitness

  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 Outcomes (1)

• changes in body composition

  measured at 1, 2, 3 and 5 years

Other Outcomes (1)

• changes in muscle strength

  will be measured before study and after 1 and 5 years

Study Arms (2)

Training group

ACTIVE COMPARATOR

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

Prescription of exercise

ACTIVE COMPARATOR

Individualized sessions for exercise prescription aiming at moderate exercise of 30 minutes at least 5 days a week

Behavioral: Physical activity

Interventions

Physical activity BEHAVIORAL

Prescription of exercise; Training group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• poor physical fitness based on repeated walking test (UKK 2 km walking test)
• non-diabetic

You may not qualify if:

• health problems complicating moderate physical training

Sponsors & Collaborators

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

Study Sites (1)

Folkhälsan Research Center

Helsinki, Finland

Location

Related Publications (1)

• Wasenius NS, Isomaa BA, Ostman B, Soderstrom J, Forsen B, Lahti K, Hakaste L, Eriksson JG, Groop L, Hansson O, Tuomi T. Low-cost exercise interventions improve long-term cardiometabolic health independently of a family history of type 2 diabetes: a randomized parallel group trial. BMJ Open Diabetes Res Care. 2020 Nov;8(2):e001377. doi: 10.1136/bmjdrc-2020-001377.

  PMID: 33219117 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bo Isomaa, MD

  Folkhälsan Research Center, Helsinki, Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2014
• First Posted: May 6, 2014
• Study Start: October 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2013
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

FI (1)