Geriatric DisorderNCT02780037
To Motivate Elderly to Move
A study testing Regulatory frame: prevention, Regulatory frame: promotion and Regulatory frame: not implied in people with Geriatric Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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+). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Disorder
- What is being tested?
- Regulatory frame: prevention, Regulatory frame: promotion and Regulatory frame: not implied
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age
Who cannot join
- severe mental/physical problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Geriatric Disorder
- Being tested
- Regulatory frame: prevention, Regulatory frame: promotion, Regulatory frame: not implied
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulatory frame: preventionBehavioural
Exercise program presented as preventing deterioration.
Regulatory frame: promotionBehavioural
Exercise program presented as promoting improvement.
Regulatory frame: not impliedBehavioural
Exercise program presented without implied consequences.
| Study group | Role | What they receive |
|---|---|---|
| Prevention | Experimental | Regulatory frame: prevention Receives: Behavioral: Regulatory frame: prevention |
| Promotion | Experimental | Regulatory frame: promotion Receives: Behavioral: Regulatory frame: promotion |
| Neutral | Sham comparator | Regulatory frame: not implied Receives: Behavioral: Regulatory frame: not implied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior at long term: exercise frequency during third week
self-reported no exercise sessions
Measured: third week
Secondary outcomes (5)
Change in controlled motivation over long term: end week 3 - baseline
baseline, end week 3 (BREQ-2 questionnaire)
Measured: 3 weeks
Change in autonomous motivation over long term: end week 3 - baseline
baseline, end week 3 (BREQ-2 questionnaire)
Measured: 3 weeks
Change in controlled motivation over short term: end week 1 - baseline
baseline, end week 1 (BREQ-2 questionnaire)
Measured: 1 week
Change in autonomous motivation over short term: end week 1 - baseline
baseline, end week 1 (BREQ-2 questionnaire)
Measured: 1 week
Behavior at short term: exercise frequency during first week
self-reported no exercise sessions
Measured: first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Geriatric DisorderStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780037
- Sponsor's protocol ID
- S58680
- Status last verified
- Feb 2016
- First submitted
- 23 Feb 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Individual data sharing
- No
Publications
Vanroy J, Seghers J, van Uffelen J, Boen F. Can a framed intervention motivate older adults in assisted living facilities to exercise? BMC Geriatr. 2019 Feb 18;19(1):46. doi: 10.1186/s12877-019-1060-z.
PubMed 30777017
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Motivate Elderly to Move: Focus on Prevention or Promotion?
- ClinicalTrials.gov ID
- NCT02780037
- Acronym / sponsor ID
- S58680
- Conditions
- Geriatric Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prevention | Experimental | Behavioral: Regulatory frame: preventionRegulatory frame: prevention |
| Promotion | Experimental | Behavioral: Regulatory frame: promotionRegulatory frame: promotion |
| Neutral | Sham comparator | Behavioral: Regulatory frame: not impliedRegulatory frame: not implied |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years of age
Key exclusion criteria (1 listed)
- severe mental/physical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regulatory frame: preventionExercise program presented as preventing deterioration. | Behavioural | Prevention |
| Regulatory frame: promotionExercise program presented as promoting improvement. | Behavioural | Promotion |
| Regulatory frame: not impliedExercise program presented without implied consequences. | Behavioural | Neutral |
Primary outcome
Behavior at long term: exercise frequency during third week
Time frame: third week
self-reported no exercise sessions
5 secondary outcomes
Change in controlled motivation over long term: end week 3 - baseline
Time frame: 3 weeks
Change in autonomous motivation over long term: end week 3 - baseline
Time frame: 3 weeks
Change in controlled motivation over short term: end week 1 - baseline
Time frame: 1 week
Change in autonomous motivation over short term: end week 1 - baseline
Time frame: 1 week
Behavior at short term: exercise frequency during first week
Time frame: first week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 30777017Vanroy J, Seghers J, van Uffelen J, Boen F. Can a framed intervention motivate older adults in assisted living facilities to exercise? BMC Geriatr. 2019 Feb 18;19(1):46. doi: 10.1186/s12877-019-1060-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regulatory frame: prevention, Regulatory frame: promotion and Regulatory frame: not implied in people with Geriatric Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior at long term: exercise frequency during third week (time frame: third week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02780037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.