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Objective Assessment and Promotion of Physical Activity in Elderly

This study is currently recruiting participants.
Verified November 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01748461
First received: December 3, 2012
Last updated: December 11, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of the present study is to evaluate the short-term and long-term effects of a cycle ergometer program on physical activity and physical fitness in elderly (65+). Therefore, physical activity, physical fitness and functionality are measured at baseline, after 10 weeks (after the intervention period), after 6 months and after 1 year.

Different coaching techniques (to promote the use of a cycle ergometer and cycle ergometer program) will also be evaluated. What is the best (coaching) approach for long-term adherence (physical activity)?


Condition Intervention
Elderly
 Behavioral: Structured intervention
Behavioral: Coach intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Change in objective and subjective measures of degree of physical activity [ Time Frame: baseline, 10 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
    Physical activity will be measured using a standardized questionnaire and a Sensewear. A Sensewear is an activity monitor (accelerometer) carried on the upper arm during several days and registers the amount of physical activity.

  • Change in objective measures of physical fitness [ Time Frame: baseline, 10 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
    Physical fitness will be measured using a standardized Six-Minute Walk Test and a Six-Minute Cycle Test.

  • Change in objective measures of functionality [ Time Frame: baseline, 10 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
    Functionality will be measured using the standardized The Physical Performance Test and 2 strength tests (hand grip and knee extension).


Secondary Outcome Measures:
  • Change in mental well-being [ Time Frame: baseline, 10 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
    Standardized questionnaire

  • Change in motivation to be physically active [ Time Frame: baseline, 10 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
    Standardized questionnaire

  • Change in self-efficacy to be physically active [ Time Frame: baseline, 10 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
    Standardized questionnaire


Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Structured intervention
Supervised cycle ergometer program
 Behavioral: Structured intervention
3x/week - 10 weeks - Support by fitness instructor - Individualised exercise program (cycle ergometer)
Active Comparator: Coach intervention
Non-supervised cycle ergometer program
 Behavioral: Coach intervention
promote autonomy - 4 visits during 10 weeks - Support by coach (encouragement) - Individualised exercise program
No Intervention: Control group
No cycle ergometer program

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 65 yrs
  • residents of a service flat
  • No frequent use of bike / cycle ergometer

Exclusion Criteria:

  • recent cardiovascular event or fracture
  • vestibular or thrombotic disorder
  • severe dementia
  • need for oxygen supplementation during daily activities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748461

Contacts
Contact: Sofie Martien 0472 52 93 37 / 016 32 91 64 sofie.martien@faber.kuleuven.be

Locations
Belgium
Faculty of Kinesiology and Rehabilitation Sciences Recruiting
Leuven, Belgium, 3001
Contact: Sofie Martien     0472 52 93 37     sofie.martien@faber.kuleuven.be    
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01748461     History of Changes
Other Study ID Numbers: ML8733
Study First Received: December 3, 2012
Last Updated: December 11, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
intervention study in elderly (65+)
cycle ergometer
physical activity
physical fitness
functionality

ClinicalTrials.gov processed this record on May 16, 2013