Objective Assessment and Promotion of Physical Activity in Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01748461
First received: December 3, 2012
Last updated: August 4, 2014
Last verified: August 2014
  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:


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


Enrollment: 105
Study Start Date: May 2013
Study Completion Date: April 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748461

Locations
Belgium
Faculty of Kinesiology and Rehabilitation Sciences
Leuven, Belgium, 3001
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: August 4, 2014
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on October 23, 2014