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NCT02320760 Clinical Trial

Physical Activity on Prescription in Overweight Older Adults

Metabolic Syndrome Clinical Trial

Official title:
Physical Activity in Prevention and Treatment of Overweight, Central Obesity and the Metabolic Syndrome - a Randomised Controlled Study in Overweight 65 Year Old Women and Men

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02320760
Other study ID # KI65
Secondary ID 04-520/2
Status Completed
Phase N/A
First received December 16, 2014
Last updated December 16, 2014
Start date January 2005
Est. completion date May 2009

Study information
Verified date December 2014
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

This randomized controlled study evaluates the effect of individualized physical activity on prescription (PAP) in older overweight adults. The primary hypothesis is that an individualized prescription of physical activity increases physical activity level in overweight older adults after 6 months. Secondary hypothesis are that the increased physical activity level will improve cardio metabolic risk factors and quality of life.

200 women and men, aged 65 with low physical activity level, overweight, and abdominal obesity, will be randomized to an intervention group or a control group. The control group receives general information about physical activity and registration of physical activity level for one week. The intervention group receives in addition an individualized physical activity on prescription with patient-centered counseling.

After six months both groups go through the same health check-up as at baseline and follow-ups take place after 12 and 24 months.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date May 2009
Est. primary completion date January 2007
Accepts healthy volunteers
Gender Both
Age group 65 Years to 69 Years
Eligibility Inclusion Criteria:

- BMI between 25 and 40

- waist circumference over 88 cm for women and 102 cm for men

- basically healthy

- mostly sedentary in their leisure time

Exclusion Criteria:

- current heart disease

- tablet or insulin treated diabetes type 2

- cancer

- other chronic serious illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Physical activity on prescription

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Outcome
Type Measure Description Time frame Safety issue
Other Quality of life 6 months No
Primary physical activity level 6 months No
Secondary cardiometabolic risk factors 6 months No
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