ExerciseNCT02762305
The Effects of the RSVP Bone Builders Program on Strength, Balance, Fall Risk and Life Satisfaction
A study testing RSVP Bone Builders Group Exercise in people with Exercise, run by California State University, Northridge at 1 site in United States.
Trial summary
The hypothesis of this study is that participation in the Retired and Senior Volunteer Program (RSVP) Bone Builders program 1 hour, twice per week, for 12 weeks may result in significant positive changes to the health status of older adult participants as demonstrated by increased leg strength and walking speed… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- RSVP Bone Builders Group Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Oct 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to walk independently with or without a cane or walker,
- not currently participating in the RSVP Bone Builders program,
- scoring at least 24/30 on the Mini-Mental State Examination (MMSE) and clearance of Physical Activity Readiness Questionnaire (Par-Q)
Who cannot join
- if they use a wheelchair in the community for mobility,
- have any known neurological, musculoskeletal, cardiopulmonary, or other medical condition that will not allow full participation in the RSVP Bone Builders program, and
- if the subjects score less than 24/30 on the MMSE
Trial locations and contacts
1 site in 1 country.
United States1 site
Equilibrium Balance Performance Center
Ventura, California, 93003
About this study
Official title: The Effects of the RSVP Bone Builders Program on Intrinsic Fall Risk Factors & Life Satisfaction
The hypothesis of this study is that participation in the Retired and Senior Volunteer Program (RSVP) Bone Builders program 1 hour, twice per week, for 12 weeks may result in significant positive changes to the health status of older adult participants as demonstrated by increased leg strength and walking speed, improved balance and balance confidence, and enhanced life satisfaction. These improvements may lead to a reduction in risk of falls.
Read the detailed description
The purpose of this study was to examine the efficacy of the RSVP Bone Builders program, to document benefits this program may have for older adults and also provide additional evidence that further confirms the importance of exercise for the older adult population. Exercise has the potential to reduce falls, injuries, emergency room visits, surgeries, insurance costs, and improve the overall quality of life in the older adult population. If the RSVP Bone Builders proves to be beneficial for older adults, the program could be recommended by healthcare and exercise professionals for their patients and clients who are at risk for falls.
- Conditions
- Exercise
- Being tested
- RSVP Bone Builders Group Exercise
- Keywords
- fall risk, RSVP bone builders, group exercise, older adults, balance confidence, life satisfaction, balance, walking speed
- Medical subject headings
- Motor Activity, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSVP Bone Builders Group ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| RSVP Bone Builder group exercise | Experimental | A group of older adults who are participating in the RSVP Bone Builder group exercise. Receives: Other: RSVP Bone Builders Group Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 Meter Walking Test
Measures gait speed
Measured: 12 weeks
Timed Up and Go Test
Measures gait speed \& fall risk
Measured: 12 weeks
Five Time Sit to Stand Test
Measures leg strength \& fall risk
Measured: 12 weeks
Computerized Dynamic Posturography with NeuroCom Smart Equitest
Measures balance abilities \& fall risk
Measured: 12 weeks
Berg Balance Scale
Measures balance abilities \& fall risk
Measured: 12 weeks
Activities-specific Balance Confidence (ABC) Scale
Measures balance confidence \& fall risk
Measured: 12 weeks
Satisfaction with Life Scale
Measures life satisfaction
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Northridge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jillian Giannini, Principal investigator, California State University, Northridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762305
- Sponsor's protocol ID
- 1516-091
- Status last verified
- Sep 2018
- First submitted
- 3 May 2016
- Last updated
- 25 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the RSVP Bone Builders Program on Intrinsic Fall Risk Factors & Life Satisfaction
- ClinicalTrials.gov ID
- NCT02762305
- Acronym / sponsor ID
- 1516-091
- Conditions
- Exercise
- Keywords
- fall risk, RSVP bone builders, group exercise, older adults, balance confidence, life satisfaction, balance, walking speed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- California State University, NorthridgeUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 4 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.
The hypothesis of this study is that participation in the Retired and Senior Volunteer Program (RSVP) Bone Builders program 1 hour, twice per week, for 12 weeks may result in significant positive changes to the health status of older adult participants as demonstrated by increased leg strength and walking speed, improved balance and balance confidence, and enhanced life satisfaction. These improvements may lead to a reduction in risk of falls.
Detailed description
The purpose of this study was to examine the efficacy of the RSVP Bone Builders program, to document benefits this program may have for older adults and also provide additional evidence that further confirms the importance of exercise for the older adult population. Exercise has the potential to reduce falls, injuries, emergency room visits, surgeries, insurance costs, and improve the overall quality of life in the older adult population. If the RSVP Bone Builders proves to be beneficial for older adults, the program could be recommended by healthcare and exercise professionals for their patients and clients who are at risk for falls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSVP Bone Builder group exercise | Experimental | Other: RSVP Bone Builders Group ExerciseA group of older adults who are participating in the RSVP Bone Builder group exercise. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to walk independently with or without a cane or walker,
- not currently participating in the RSVP Bone Builders program,
- scoring at least 24/30 on the Mini-Mental State Examination (MMSE) and clearance of Physical Activity Readiness Questionnaire (Par-Q)
Key exclusion criteria (3 listed)
- if they use a wheelchair in the community for mobility,
- have any known neurological, musculoskeletal, cardiopulmonary, or other medical condition that will not allow full participation in the RSVP Bone Builders program, and
- if the subjects score less than 24/30 on the MMSE
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 |
|---|---|---|
| RSVP Bone Builders Group Exercise | Other | RSVP Bone Builder group exercise |
Primary outcome
10 Meter Walking Test
Time frame: 12 weeks
Measures gait speed
Timed Up and Go Test
Time frame: 12 weeks
Measures gait speed \& fall risk
Five Time Sit to Stand Test
Time frame: 12 weeks
Measures leg strength \& fall risk
Computerized Dynamic Posturography with NeuroCom Smart Equitest
Time frame: 12 weeks
Measures balance abilities \& fall risk
Berg Balance Scale
Time frame: 12 weeks
Measures balance abilities \& fall risk
Activities-specific Balance Confidence (ABC) Scale
Time frame: 12 weeks
Measures balance confidence \& fall risk
Satisfaction with Life Scale
Time frame: 12 weeks
Measures life satisfaction
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 25 Sep 2018.
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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.
Jillian Giannini principal investigator
California State University, Northridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RSVP Bone Builders Group Exercise in people with Exercise, run by California State University, Northridge at 1 site in United States.
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 3 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 25 Sep 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 United States. 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?
10 Meter Walking Test (time frame: 12 weeks). The study lists 7 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 25 Sep 2018.