We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Objective Assessment and Promotion of Physical Activity in Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01748461
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Elderly Behavioral: Structured intervention Behavioral: Coach intervention

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : May 2013
Primary Completion Date : January 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change in objective and subjective measures of degree of physical activity [ Time Frame: baseline, 10 weeks, 6 months, 1 year ]
    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.

  2. Change in objective measures of physical fitness [ Time Frame: baseline, 10 weeks, 6 months, 1 year ]
    Physical fitness will be measured using a standardized Six-Minute Walk Test and a Six-Minute Cycle Test.

  3. Change in objective measures of functionality [ Time Frame: baseline, 10 weeks, 6 months, 1 year ]
    Functionality will be measured using the standardized The Physical Performance Test and 2 strength tests (hand grip and knee extension).


Secondary Outcome Measures :
  1. Change in mental well-being [ Time Frame: baseline, 10 weeks, 6 months, 1 year ]
    Standardized questionnaire

  2. Change in motivation to be physically active [ Time Frame: baseline, 10 weeks, 6 months, 1 year ]
    Standardized questionnaire

  3. Change in self-efficacy to be physically active [ Time Frame: baseline, 10 weeks, 6 months, 1 year ]
    Standardized questionnaire


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748461


Locations
Belgium
Faculty of Kinesiology and Rehabilitation Sciences
Leuven, Belgium, 3001
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01748461     History of Changes
Other Study ID Numbers: ML8733
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014

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