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PPP-Botnia Exercise Intervention Study

Primary Purpose

Family History of Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Folkhälsan Researech Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Family History of Type 2 Diabetes focused on measuring Physical fitness, Family history of type 2 diabetes, Prescription of exercise

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Folkhälsan Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Training group

Prescription of exercise

Arm 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.

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

Outcomes

Primary Outcome Measures

improvement in physical fitness
Fitness will be measured by a 2 km walking test, which is an indirect measure of oxygen uptake

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2014
Last Updated
May 5, 2014
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
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1. Study Identification

Unique Protocol Identification Number
NCT02131701
Brief Title
PPP-Botnia Exercise Intervention Study
Official Title
PPP-Botnia Exercise Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family History of Type 2 Diabetes
Keywords
Physical fitness, Family history of type 2 diabetes, Prescription of exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training group
Arm Type
Active Comparator
Arm 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.
Arm Title
Prescription of exercise
Arm Type
Active Comparator
Arm Description
Individualized sessions for exercise prescription aiming at moderate exercise of 30 minutes at least 5 days a week
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Primary Outcome Measure Information:
Title
improvement in physical fitness
Description
Fitness will be measured by a 2 km walking test, which is an indirect measure of oxygen uptake
Time Frame
will be measured at 1, 2,3 and 5 years
Secondary Outcome Measure Information:
Title
changes in body composition
Description
body composition will be measured as weight, waist, fat percentage
Time Frame
measured at 1, 2, 3 and 5 years
Other Pre-specified Outcome Measures:
Title
changes in muscle strength
Description
muscle strength will be followed by the method of one repetition maximum
Time Frame
will be measured before study and after 1 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Isomaa, MD
Organizational Affiliation
Folkhälsan Research Center, Helsinki, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Folkhälsan Research Center
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33219117
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.
Results Reference
derived

Learn more about this trial

PPP-Botnia Exercise Intervention Study

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