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Physical Activity on Prescription in Overweight Older Adults

Primary Purpose

Low Physical Activity Level, Central Obesity, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical activity on prescription
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Physical Activity Level

Eligibility Criteria

65 Years - 69 Years (Older Adult)All Sexes

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Physical activity on prescription

    Ordinary care

    Arm Description

    Outcomes

    Primary Outcome Measures

    physical activity level

    Secondary Outcome Measures

    cardiometabolic risk factors

    Full Information

    First Posted
    December 16, 2014
    Last Updated
    December 16, 2014
    Sponsor
    Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02320760
    Brief Title
    Physical Activity on Prescription in Overweight Older Adults
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    May 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Physical Activity Level, Central Obesity, Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical activity on prescription
    Arm Type
    Experimental
    Arm Title
    Ordinary care
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical activity on prescription
    Primary Outcome Measure Information:
    Title
    physical activity level
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    cardiometabolic risk factors
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Quality of life
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    69 Years
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26193882
    Citation
    Olsson SJ, Borjesson M, Ekblom-Bak E, Hemmingsson E, Hellenius ML, Kallings LV. Effects of the Swedish physical activity on prescription model on health-related quality of life in overweight older adults: a randomised controlled trial. BMC Public Health. 2015 Jul 21;15:687. doi: 10.1186/s12889-015-2036-3.
    Results Reference
    derived

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    Physical Activity on Prescription in Overweight Older Adults

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