Objective Assessment and Promotion of Physical Activity in Elderly
1 other identifier
interventional
105
1 country
1
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)?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2012
CompletedFirst Posted
Study publicly available on registry
December 12, 2012
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedAugust 5, 2014
August 1, 2014
8 months
December 3, 2012
August 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Secondary Outcomes (3)
Change in mental well-being
baseline, 10 weeks, 6 months, 1 year
Change in motivation to be physically active
baseline, 10 weeks, 6 months, 1 year
Change in self-efficacy to be physically active
baseline, 10 weeks, 6 months, 1 year
Study Arms (3)
Structured intervention
ACTIVE COMPARATORSupervised cycle ergometer program
Coach intervention
ACTIVE COMPARATORNon-supervised cycle ergometer program
Control group
NO INTERVENTIONNo cycle ergometer program
Interventions
3x/week - 10 weeks - Support by fitness instructor - Individualised exercise program (cycle ergometer)
promote autonomy - 4 visits during 10 weeks - Support by coach (encouragement) - Individualised exercise program
Eligibility Criteria
You may qualify if:
- yrs
- residents of a service flat
- No frequent use of bike / cycle ergometer
You may not qualify if:
- recent cardiovascular event or fracture
- vestibular or thrombotic disorder
- severe dementia
- need for oxygen supplementation during daily activities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Kinesiology and Rehabilitation Sciences
Leuven, 3001, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2012
First Posted
December 12, 2012
Study Start
May 1, 2013
Primary Completion
January 1, 2014
Study Completion
April 1, 2014
Last Updated
August 5, 2014
Record last verified: 2014-08