Healthy AgingPhase 1NCT02218411
Video-supported Group-based Otago Exercise Programme on Physical Performance in Older Adults.
A Phase 1 study testing Exercise training in people with Healthy Aging, run by Cardenal Herrera University.
Trial summary
The purpose of this study was to evaluate the effects of a video-supported group-based Otago exercise programme intervention on balance, mobility, physical performance and aerobic endurance in community-dwelling older adults 65+ years old. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Jan 2013
- Phase
- Phase 1
- 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
- Aged 65 years and older.
- Living in the community (Valencia, Spain).
- Able to ambulate independently without a walking aid.
- Have no severe medical contraindication for physical activity.
- Able to communicate.
- Have self-reported visual and auditory capacities to follow commands.
- Provide signed informed consent.
Who cannot join
- Unable to ambulate independently.
- Mini-mental state examination score of <24.
- Barthel Index score of <80.
- Severe visual and auditory disabilities.
- Unstable cardiovascular disease.
- Neurological disorder that could compromise them from exercising.
- Upper or lower extremity fracture in the past year.
About this study
Official title: Effectiveness of a Video-supported Group-based Otago Exercise Programme on Physical Performance in Community-dwelling Older Adults: a Pilot Randomized Controlled Trial
The purpose of this study was to evaluate the effects of a video-supported group-based Otago exercise programme intervention on balance, mobility, physical performance and aerobic endurance in community-dwelling older adults 65+ years old.
- Conditions
- Healthy Aging
- Being tested
- Exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Exercises routine based on the Otago exercise programme
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercises routine based on the Otago exercise programme Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Timed Up and Go test
General mobility measurement
Measured: Pre intervention and after 4-month intervention
Secondary outcomes (4)
Change in the Berg Balance Scale
Functional Balance measurement
Measured: Pre intervention and after 4-month intervention
Change in the 6.min Walk Test
Aerobic Endurance Measurement
Measured: Pre intervention and after 4-month intervention
Change in the One-Leg Stand
One-leg Balance Measurement
Measured: Pre intervention and after 4-month intervention
Change in the Short Physical Performance Battery
Lower Limb Functional Measurement
Measured: Pre intervention and after 4-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startSep 2012
- Primary completionSep 2012
- Study completionJan 2013
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 Healthy AgingStudies 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 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Vicent Benavent-Caballer, PT, MS, Principal investigator, CEU UCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218411
- Sponsor's protocol ID
- CEU UCH
- Status last verified
- Aug 2014
- First submitted
- 14 Jul 2014
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Benavent-Caballer V, Rosado-Calatayud P, Segura-Orti E, Amer-Cuenca JJ, Lison JF. The effectiveness of a video-supported group-based Otago exercise programme on physical performance in community-dwelling older adults: a preliminary study. Physiotherapy. 2016 Sep;102(3):280-6. doi: 10.1016/j.physio.2015.08.002. Epub 2015 Sep 1.
PubMed 26395209
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Video-supported Group-based Otago Exercise Programme on Physical Performance in Community-dwelling Older Adults: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02218411
- Acronym / sponsor ID
- CEU UCH
- Conditions
- Healthy Aging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 Aug 2014 (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 this study was to evaluate the effects of a video-supported group-based Otago exercise programme intervention on balance, mobility, physical performance and aerobic endurance in community-dwelling older adults 65+ years old.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise trainingExercises routine based on the Otago exercise programme |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Aged 65 years and older.
- Living in the community (Valencia, Spain).
- Able to ambulate independently without a walking aid.
- Have no severe medical contraindication for physical activity.
- Able to communicate.
Key exclusion criteria (7 listed)
- Unable to ambulate independently.
- Mini-mental state examination score of <24.
- Barthel Index score of <80.
- Severe visual and auditory disabilities.
- Unstable cardiovascular disease.
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 |
|---|---|---|
| Exercise trainingExercises routine based on the Otago exercise programme | Other | Exercise |
Primary outcome
Change in the Timed Up and Go test
Time frame: Pre intervention and after 4-month intervention
General mobility measurement
4 secondary outcomes
Change in the Berg Balance Scale
Time frame: Pre intervention and after 4-month intervention
Change in the 6.min Walk Test
Time frame: Pre intervention and after 4-month intervention
Change in the One-Leg Stand
Time frame: Pre intervention and after 4-month intervention
Change in the Short Physical Performance Battery
Time frame: Pre intervention and after 4-month intervention
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 18 Aug 2014.
- Derived from this study: PubMed 26395209Benavent-Caballer V, Rosado-Calatayud P, Segura-Orti E, Amer-Cuenca JJ, Lison JF. The effectiveness of a video-supported group-based Otago exercise programme on physical performance in community-dwelling older adults: a preliminary study. Physiotherapy. 2016 Sep;102(3):280-6. doi: 10.1016/j.physio.2015.08.002. Epub 2015 Sep 1.
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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.
Vicent Benavent-Caballer, PT, MS principal investigator
CEU UCH
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise training in people with Healthy Aging, run by Cardenal Herrera University.
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 7 inclusion and 7 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 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 the Timed Up and Go test (time frame: Pre intervention and after 4-month intervention). 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 NCT02218411, 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 18 Aug 2014.