AgingNCT02981771
The Effect of Exercise Training Programs On Balance in Older Adults With CVD
A study testing Balance activity program and Strength activity program in people with Aging and Cardiovascular Diseases, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Individuals of advanced age with cardiovascular disease are at higher risk of fall.The aim of this study is to explore the effect of specific exercise program based on balance and coordination on stability parameters Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Cardiovascular Diseases
- What is being tested?
- Balance activity program and Strength activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Feb 2017to 25 Dec 2017
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Has Cardiovascular disease, under the supervision of a cardiologist
- Participates in a cardiovascular rehabilitation center
- Able to undergo physical activity for 60 minutes twice a week
Who cannot join
- All Other
Trial locations and contacts
1 site in 1 country.
Israel1 site
Zinman College for Physical Education and Sport Sciences
Ramot Naftali, 42902
About this study
Official title: The Effect of Exercise Training Programs - Stability and Coordination - On Static Balance, Dynamic Balance and Risk of Falls in Older Adults With Cardiovascular Disease
Individuals of advanced age with cardiovascular disease are at higher risk of fall.The aim of this study is to explore the effect of specific exercise program based on balance and coordination on stability parameters
- Conditions
- Aging, Cardiovascular Diseases
- Being tested
- Balance activity program, Strength activity program
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance activity programBehavioural
Participants will take part in a biweekly, 12 week physical activity program that will include balance and coordination exercises
Strength activity programBehavioural
Participants will take part in a biweekly, 12 week physical activity program that will include traditional strength exercises
| Study group | Role | What they receive |
|---|---|---|
| experiment | Experimental | A physical activity program that is based on balance and coordination exercises Receives: Behavioral: Balance activity program |
| control | Placebo comparator | A physical activity program that is based on strength exercises Receives: Behavioral: Strength activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Balance ability - a composite outcome
In order to assess changes in balance ability, it will be measured with the following tests:
Timed Get Up and Go , Balance Error Scoring System Test, Functional Reach Test, before and after the 12 week physical activity program and the difference will be compared
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start8 Feb 2017
- Primary completion31 Jul 2017
- Study completion25 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981771
- Sponsor's protocol ID
- 0083-16-HYMC
- Status last verified
- Oct 2018
- First submitted
- 29 Nov 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Training Programs - Stability and Coordination - On Static Balance, Dynamic Balance and Risk of Falls in Older Adults With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT02981771
- Acronym / sponsor ID
- 0083-16-HYMC
- Conditions
- Aging, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 25 Dec 2017 (actual)
- First posted
- 5 Dec 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.
Individuals of advanced age with cardiovascular disease are at higher risk of fall.The aim of this study is to explore the effect of specific exercise program based on balance and coordination on stability parameters
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment | Experimental | Behavioral: Balance activity programA physical activity program that is based on balance and coordination exercises |
| control | Placebo comparator | Behavioral: Strength activity programA physical activity program that is based on strength exercises |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Has Cardiovascular disease, under the supervision of a cardiologist
- Participates in a cardiovascular rehabilitation center
- Able to undergo physical activity for 60 minutes twice a week
Key exclusion criteria (1 listed)
- All Other
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 |
|---|---|---|
| Balance activity programParticipants will take part in a biweekly, 12 week physical activity program that will include balance and coordination exercises | Behavioural | experiment |
| Strength activity programParticipants will take part in a biweekly, 12 week physical activity program that will include traditional strength exercises | Behavioural | control |
Primary outcome
Change in Balance ability - a composite outcome
Time frame: 4 months
In order to assess changes in balance ability, it will be measured with the following tests: Timed Get Up and Go , Balance Error Scoring System Test, Functional Reach Test, before and after the 12 week physical activity program and the difference will be compared
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 17 Oct 2018.
Related trials for Aging
Enrolling by invitationPhase 2
Tirzepatide and Organ-specific Biological Aging
Longevity, Preventive Medicine
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
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 Balance activity program and Strength activity program in people with Aging and Cardiovascular Diseases, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 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 17 Oct 2018. 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 Israel. 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?
Change in Balance ability - a composite outcome (time frame: 4 months). 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 17 Oct 2018.