NCT01748461

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

8 months

First QC Date

December 3, 2012

Last Update Submit

August 4, 2014

Conditions

Keywords

intervention study in elderly (65+)cycle ergometerphysical activityphysical fitnessassisted living facility

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 COMPARATOR

Supervised cycle ergometer program

Behavioral: Structured intervention

Coach intervention

ACTIVE COMPARATOR

Non-supervised cycle ergometer program

Behavioral: Coach intervention

Control group

NO INTERVENTION

No cycle ergometer program

Interventions

3x/week - 10 weeks - Support by fitness instructor - Individualised exercise program (cycle ergometer)

Structured intervention

promote autonomy - 4 visits during 10 weeks - Support by coach (encouragement) - Individualised exercise program

Coach intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

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

Locations