Objective Assessment and Promotion of Physical Activity in Elderly

August 4, 2014 updated by: Universitaire Ziekenhuizen KU Leuven

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)?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3001
        • Faculty of Kinesiology and Rehabilitation Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 10 weeks, 6 months, 1 year
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.
baseline, 10 weeks, 6 months, 1 year
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).
baseline, 10 weeks, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mental well-being
Time Frame: baseline, 10 weeks, 6 months, 1 year
Standardized questionnaire
baseline, 10 weeks, 6 months, 1 year
Change in motivation to be physically active
Time Frame: baseline, 10 weeks, 6 months, 1 year
Standardized questionnaire
baseline, 10 weeks, 6 months, 1 year
Change in self-efficacy to be physically active
Time Frame: baseline, 10 weeks, 6 months, 1 year
Standardized questionnaire
baseline, 10 weeks, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ML8733

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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