- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02780037
To Motivate Elderly to Move
November 2, 2017 updated by: Universitaire Ziekenhuizen KU Leuven
To Motivate Elderly to Move: Focus on Prevention or Promotion?
This study examines the short- and long-term-effects of different repeated frames in which an exercise program is offered on behavior (i.e., frequency of exercise) and motivation (i.e., autonomous/controlled) in older people (65+).
The frames are manipulated experimentally as either prevention focused (e.g., to prevent worse health), promotion focused (e.g., to gain better health) or neutral (control condition).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
111
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
-
-
Vlaams-Brabant
-
Leuven (Heverlee), Vlaams-Brabant, Belgium, 3001
- Department of Kinesiology
-
-
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 years of age
Exclusion Criteria:
- severe mental/physical problems
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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prevention
Regulatory frame: prevention
|
Exercise program presented as preventing deterioration.
|
|
Experimental: Promotion
Regulatory frame: promotion
|
Exercise program presented as promoting improvement.
|
|
Sham Comparator: Neutral
Regulatory frame: not implied
|
Exercise program presented without implied consequences.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavior at long term: exercise frequency during third week
Time Frame: third week
|
self-reported no exercise sessions
|
third week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in controlled motivation over long term: end week 3 - baseline
Time Frame: 3 weeks
|
baseline, end week 3 (BREQ-2 questionnaire)
|
3 weeks
|
|
Change in autonomous motivation over long term: end week 3 - baseline
Time Frame: 3 weeks
|
baseline, end week 3 (BREQ-2 questionnaire)
|
3 weeks
|
|
Change in controlled motivation over short term: end week 1 - baseline
Time Frame: 1 week
|
baseline, end week 1 (BREQ-2 questionnaire)
|
1 week
|
|
Change in autonomous motivation over short term: end week 1 - baseline
Time Frame: 1 week
|
baseline, end week 1 (BREQ-2 questionnaire)
|
1 week
|
|
Behavior at short term: exercise frequency during first week
Time Frame: first week
|
self-reported no exercise sessions
|
first week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functionality: sit to stand/sit: flexion, extension, stand and sit duration (time)
Time Frame: week 1/week 2/week 3
|
(Dynaport)
|
week 1/week 2/week 3
|
|
Functionality: sit to stand/sit: angular velocity flexion and extension (degrees/sec)
Time Frame: week 1/week 2/week 3
|
(Dynaport)
|
week 1/week 2/week 3
|
|
Functionality: sit to stand/sit: range flexion and extension (degrees)
Time Frame: week 1/week 2/week 3
|
(Dynaport)
|
week 1/week 2/week 3
|
|
Functionality: SPPB (Short Physical Performance Battery) score
Time Frame: week 1/week 2/week 3
|
(Dynaport)
|
week 1/week 2/week 3
|
|
Functionality: SPPB balance score
Time Frame: week 1/week 2/week 3
|
(Dynaport)
|
week 1/week 2/week 3
|
|
Functionality: SPPB gait speed score
Time Frame: week 1/week 2/week 3
|
(Dynaport)
|
week 1/week 2/week 3
|
|
Functionality: SPPB chair stand score
Time Frame: week 1/week 2/week 3
|
(Dynaport)
|
week 1/week 2/week 3
|
|
Functionality: sway acceleration (mG)
Time Frame: week 1/week 2/week 3
|
(Dynaport)
|
week 1/week 2/week 3
|
|
Functionality: sway velocity (mm/sec)
Time Frame: week 1/week 2/week 3
|
(Dynaport)
|
week 1/week 2/week 3
|
|
Functionality: sway path (mm/sec)
Time Frame: week 1/week 2/week 3
|
(Dynaport)
|
week 1/week 2/week 3
|
|
Functionality: sway normalized area (mm²/sec)
Time Frame: week 1/week 2/week 3
|
(Dynaport)
|
week 1/week 2/week 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
February 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
February 23, 2016
First Submitted That Met QC Criteria
May 18, 2016
First Posted (Estimate)
May 23, 2016
Study Record Updates
Last Update Posted (Actual)
November 6, 2017
Last Update Submitted That Met QC Criteria
November 2, 2017
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- S58680
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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