Objective Assessment and Promotion of Physical Activity in Elderly

Elderly Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748461
• Other study ID #: ML8733
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: August 4, 2014
• Start date: May 2013
• Est. completion date: April 2014

Study information

• Verified date: August 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Elderly

Intervention

Behavioral:
• Structured intervention
3x/week - 10 weeks - Support by fitness instructor - Individualised exercise program (cycle ergometer)
• Coach intervention
promote autonomy - 4 visits during 10 weeks - Support by coach (encouragement) - Individualised exercise program

Locations

Country	Name	City	State
Belgium	Faculty of Kinesiology and Rehabilitation Sciences	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in objective and subjective measures of degree of physical activity	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	No
Primary	Change in objective measures of physical fitness	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	No
Primary	Change in objective measures of functionality	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	No
Secondary	Change in mental well-being	Standardized questionnaire	baseline, 10 weeks, 6 months, 1 year	No
Secondary	Change in motivation to be physically active	Standardized questionnaire	baseline, 10 weeks, 6 months, 1 year	No
Secondary	Change in self-efficacy to be physically active	Standardized questionnaire	baseline, 10 weeks, 6 months, 1 year	No