Clinical trial NCT02131701: PPP-Botnia Exercise Intervention Study
Official title: PPP-Botnia Exercise Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family History of Type 2 Diabetes
Keywords: Physical fitness
Family history of type 2 diabetes
Prescription of exercise
Lead sponsor: Folkhälsan Researech Center
Sponsor class: OTHER
Collaborators: name: Närpes Health Care Center, Närpes, Finland
name: Department of Social Services and Health Care, Jakobstad, Finland
name: Department of Clinical Sciences, Lund University Diabetes Center, CRC, Lund University, Malmö, Sweden
First posted: 2014-05-06
Enrollment: 290
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: improvement in physical fitness
timeFrame: will be measured at 1, 2,3 and 5 years
Secondary outcomes:
measure: changes in body composition
timeFrame: measured at 1, 2, 3 and 5 years
Other outcomes:
measure: changes in muscle strength
timeFrame: will be measured before study and after 1 and 5 years
Locations:
city: Helsinki
country: Finland
facility: Folkhälsan Research Center
Study officials:
affiliation: Folkhälsan Research Center, Helsinki, Finland
name: Bo Isomaa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.