ElderlyNCT01748461
Objective Assessment and Promotion of Physical Activity in Elderly
A study testing Structured intervention and Coach intervention in people with Elderly, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Structured intervention and Coach intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- May 2013to Apr 2014
- 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 yrs
- residents of a service flat
- No frequent use of bike / cycle ergometer
Who cannot join
- recent cardiovascular event or fracture
- vestibular or thrombotic disorder
- severe dementia
- need for oxygen supplementation during daily activities
Trial locations and contacts
1 site in 1 country.
About this study
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)?
- Conditions
- Elderly
- Being tested
- Structured intervention, Coach intervention
- Keywords
- intervention study in elderly (65+), cycle ergometer, physical activity, physical fitness, assisted living facility
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured interventionBehavioural
3x/week - 10 weeks - Support by fitness instructor - Individualised exercise program (cycle ergometer)
Coach interventionBehavioural
promote autonomy - 4 visits during 10 weeks - Support by coach (encouragement) - Individualised exercise program
| Study group | Role | What they receive |
|---|---|---|
| Structured intervention | Active comparator | Supervised cycle ergometer program Receives: Behavioral: Structured intervention |
| Coach intervention | Active comparator | Non-supervised cycle ergometer program Receives: Behavioral: Coach intervention |
| Control group | No intervention | No cycle ergometer program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: baseline, 10 weeks, 6 months, 1 year
Secondary outcomes (3)
Change in mental well-being
Standardized questionnaire
Measured: baseline, 10 weeks, 6 months, 1 year
Change in motivation to be physically active
Standardized questionnaire
Measured: baseline, 10 weeks, 6 months, 1 year
Change in self-efficacy to be physically active
Standardized questionnaire
Measured: baseline, 10 weeks, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 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
- NCT01748461
- Sponsor's protocol ID
- ML8733
- Status last verified
- Aug 2014
- First submitted
- 3 Dec 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment and Promotion of Physical Activity in Elderly
- ClinicalTrials.gov ID
- NCT01748461
- Acronym / sponsor ID
- ML8733
- Conditions
- Elderly
- Keywords
- intervention study in elderly (65+), cycle ergometer, physical activity, physical fitness, assisted living facility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Dec 2012 (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.
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)?
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Structured intervention | Active comparator | Behavioral: Structured interventionSupervised cycle ergometer program |
| Coach intervention | Active comparator | Behavioral: Coach interventionNon-supervised cycle ergometer program |
| Control group | No intervention | –No cycle ergometer program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 yrs
- residents of a service flat
- No frequent use of bike / cycle ergometer
Key exclusion criteria (4 listed)
- recent cardiovascular event or fracture
- vestibular or thrombotic disorder
- severe dementia
- need for oxygen supplementation during daily activities
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 |
|---|---|---|
| Structured intervention3x/week - 10 weeks - Support by fitness instructor - Individualised exercise program (cycle ergometer) | Behavioural | Structured intervention |
| Coach interventionpromote autonomy - 4 visits during 10 weeks - Support by coach (encouragement) - Individualised exercise program | Behavioural | Coach intervention |
Primary outcome
Change in objective and subjective measures of degree of physical activity
Time frame: baseline, 10 weeks, 6 months, 1 year
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.
Change in objective measures of physical fitness
Time frame: baseline, 10 weeks, 6 months, 1 year
Physical fitness will be measured using a standardized Six-Minute Walk Test and a Six-Minute Cycle Test.
Change in objective measures of functionality
Time frame: baseline, 10 weeks, 6 months, 1 year
Functionality will be measured using the standardized The Physical Performance Test and 2 strength tests (hand grip and knee extension).
3 secondary outcomes
Change in mental well-being
Time frame: baseline, 10 weeks, 6 months, 1 year
Change in motivation to be physically active
Time frame: baseline, 10 weeks, 6 months, 1 year
Change in self-efficacy to be physically active
Time frame: baseline, 10 weeks, 6 months, 1 year
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 5 Aug 2014.
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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 Structured intervention and Coach intervention in people with Elderly, 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 3 inclusion and 4 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 5 Aug 2014. 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. 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?
Change in objective and subjective measures of degree of physical activity (time frame: baseline, 10 weeks, 6 months, 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2014.