PPP-Botnia Exercise Intervention Study

Folkhälsan Researech Center

Status: Completed

Conditions: Family History of Type 2 Diabetes

Treatments: Behavioral: Physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT02131701

PPP2007

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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290 participants in 2 patient groups

Training group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical activity

Prescription of exercise

Active Comparator group

Description:

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

Treatment:

Behavioral: Physical activity