Community-dwelling Older AdultsMME-CDOANCT03951688
Multi-modal Exercise Program in Older Adults
A study testing Experimental-Multi-modal exercise program in people with Community-dwelling Older Adults, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Aim: To evaluate the short-term effects of a multi-modal exercise program on physical performance variables in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community-dwelling Older Adults
- What is being tested?
- Experimental-Multi-modal exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 31 May 2019to 10 Jan 2020
- 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
- Age ≥ 65 years
- Community-dwelling
Who cannot join
- Unable to ambulate independently
- Mini-mental state examination score < 24
- Barthel Index score < 80
- Unstable cardiovascular disease
- Neurological disorder that could compromise exercising
- Upper or lower-extremity fracture in the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Multi-modal Exercise Program in Community-dwelling Older Adults
Aim: To evaluate the short-term effects of a multi-modal exercise program on physical performance variables in older adults.
Read the detailed description
- Aim: To evaluate the short-term effects of a 16 weeks home-based multi-modal exercise program on physical performance variables in community-dwelling older adults.
- Design: randomized controlled trial.
- Setting: home-based intervention.
- Conditions
- Community-dwelling Older Adults
- Being tested
- Experimental-Multi-modal exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental-Multi-modal exercise programOther
Each home-based session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking.
Finally, participants are instructed to walk at their usual pace for at least 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental-Multi-modal exercise program | Experimental | Each home-based session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking.
Finally, participants are instructed to walk at their usual pace for at least 10 minutes. Receives: Other: Experimental-Multi-modal exercise program |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed 'Up-and-Go' test (TUG)
The participants are instructed to stand up from a standard chair of 45 cm height, walk 3 metre, turn around a cone, return to the chair, and sit down again in the shortest time possible without running. Two trials are performed, and the quicker time in seconds is recorded. Shorter time indicates better performance.
Measured: 16 weeks
Secondary outcomes (2)
Repeated chair stand test (STS-5)
The participants are instructed to stand from a chair five successive times as quickly as possible without the assistance of their arms. Shorter time indicates better performance.
Measured: 16 weeks
One-Leg Stand test (OLS)
Participants are instructed to start the test from a standing position with their eyes open and arms at their sides, choose a leg to stand on, flex the opposite knee, allowing the foot to clear the ground, and stand unassisted on one leg as long as possible. Longer time indicates better performance.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start31 May 2019
- Primary completion28 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-dwelling Older AdultsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
- Investigators
- JF Lisón, PhD, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951688
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-21
- Acronym
- MME-CDOA
- Status last verified
- Feb 2020
- First submitted
- 14 May 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multi-modal Exercise Program in Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT03951688
- Acronym / sponsor ID
- MME-CDOA / UNIVERSITY CARDENAL HERRERA-21
- Conditions
- Community-dwelling Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 15 May 2019 (actual)
- 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.
Aim: To evaluate the short-term effects of a multi-modal exercise program on physical performance variables in older adults.
Detailed description
- Aim: To evaluate the short-term effects of a 16 weeks home-based multi-modal exercise program on physical performance variables in community-dwelling older adults.
- Design: randomized controlled trial.
- Setting: home-based intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental-Multi-modal exercise program | Experimental | Other: Experimental-Multi-modal exercise programEach home-based session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking. Finally, participants are instructed to walk at their usual pace for at least 10 minutes. |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age ≥ 65 years
- Community-dwelling
Key exclusion criteria (6 listed)
- Unable to ambulate independently
- Mini-mental state examination score < 24
- Barthel Index score < 80
- Unstable cardiovascular disease
- Neurological disorder that could compromise exercising
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 |
|---|---|---|
| Experimental-Multi-modal exercise programEach home-based session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking. Finally, participants are instructed to walk at their usual pace for at least 10 minutes. | Other | Experimental-Multi-modal exercise program |
Primary outcome
Timed 'Up-and-Go' test (TUG)
Time frame: 16 weeks
The participants are instructed to stand up from a standard chair of 45 cm height, walk 3 metre, turn around a cone, return to the chair, and sit down again in the shortest time possible without running. Two trials are performed, and the quicker time in seconds is recorded. Shorter time indicates better performance.
2 secondary outcomes
Repeated chair stand test (STS-5)
Time frame: 16 weeks
One-Leg Stand test (OLS)
Time frame: 16 weeks
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 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
JF Lisón, PhD principal investigator
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental-Multi-modal exercise program in people with Community-dwelling Older Adults, run by Cardenal Herrera University at 1 site in Spain.
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 2 inclusion and 6 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 Feb 2020. 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 Spain. 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?
Timed 'Up-and-Go' test (TUG) (time frame: 16 weeks). 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 6 Feb 2020.