- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02762305
The Effects of the RSVP Bone Builders Program on Strength, Balance, Fall Risk and Life Satisfaction
September 21, 2018 updated by: California State University, Northridge
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Ventura, California, United States, 93003
- Equilibrium Balance Performance Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RSVP Bone Builder group exercise
A group of older adults who are participating in the RSVP Bone Builder group exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10 Meter Walking Test
Time Frame: 12 weeks
|
Measures gait speed
|
12 weeks
|
|
Timed Up and Go Test
Time Frame: 12 weeks
|
Measures gait speed & fall risk
|
12 weeks
|
|
Five Time Sit to Stand Test
Time Frame: 12 weeks
|
Measures leg strength & fall risk
|
12 weeks
|
|
Computerized Dynamic Posturography with NeuroCom Smart Equitest
Time Frame: 12 weeks
|
Measures balance abilities & fall risk
|
12 weeks
|
|
Berg Balance Scale
Time Frame: 12 weeks
|
Measures balance abilities & fall risk
|
12 weeks
|
|
Activities-specific Balance Confidence (ABC) Scale
Time Frame: 12 weeks
|
Measures balance confidence & fall risk
|
12 weeks
|
|
Satisfaction with Life Scale
Time Frame: 12 weeks
|
Measures life satisfaction
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jillian Giannini, California State University, Northridge
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
May 3, 2016
First Submitted That Met QC Criteria
May 3, 2016
First Posted (Estimate)
May 4, 2016
Study Record Updates
Last Update Posted (Actual)
September 25, 2018
Last Update Submitted That Met QC Criteria
September 21, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1516-091
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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