- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06671847
Feasibility of At-Home Chair-Based Resistance Band Training to Improve Balance, Strength, and Bone Density in Older Adults (ChaREx)
November 1, 2024 updated by: Nahid Rianon, The University of Texas Health Science Center, Houston
Feasibility of 24-Weeks of At-Home Chair-Based Resistance Band Training to Improve Balance, Strength, and Bone Density in Older Adults (ChaREx Study)
The purpose of this study is to determine the feasibility of implementing a 24-week at-home chair-based resistance band training intervention, to determine effectiveness of a the a 24-week at-home chair-based resistance band training intervention in improving body composition and to determine the effectiveness of a 24-week at-home chair-based resistance band training intervention in improving physical performance in adults 50 years and older, receiving care at the UT Physicians Center for Healthy Aging.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
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 Contact
- Name: Nahid Rianon, MBBS,DrPH
- Phone Number: (713) 500-5106
- Email: Nahid.J.Rianon@uth.tmc.edu
Study Contact Backup
- Name: Jude des Bordes, MBChB, DrPH
- Phone Number: (713) 500-6029
- Email: Jude.K.desBordes@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77479
- The University of Texas Health Science Center at Houston
-
Contact:
- Jude des Bordes, MBChB, DrPH
- Phone Number: (713) 500-6029
- Email: Jude.K.desBordes@uth.tmc.edu
-
Contact:
- Nahid Rianon, MBBS,DrPH
- Phone Number: 713-500-5106
- Email: Nahid.J.Rianon@uth.tmc.edu
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- English-speaking
- receive care at the UT Physician Center for Healthy Aging
Exclusion Criteria:
- inability to provide informed consent on their own
- presence of obvious signs of cognitive decline
- a diagnosis of dementia and inability to come to the clinic for the scheduled study visits.
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chair-based resistance band training
|
The training will be performed using THERABand resistance exercise bands.Participants will be instructed to perform the exercises twice per week at home, for the 24 weeks duration.
Each exercise session will entail 1 set of 15 repetitions of 9 different exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Feasibility as assessed by the number of people who are able to follow the prescribed exercise regimen at least 50 percent of the time
Time Frame: end of study (24 weeks from baseline)
|
end of study (24 weeks from baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in body fat
Time Frame: baseline,6-months
|
This will be assessed using the handheld bioelectrical impedance analysis (BIA) device (Omron HBF-510)
|
baseline,6-months
|
|
Change in bone mineral density (BMD) of the femoral neck and lumbar spine
Time Frame: baseline, 1 year from baseline
|
This will be assessed by the Dual energy x-ray absorptiometry (DXA)
|
baseline, 1 year from baseline
|
|
Handgrip strength
Time Frame: baseline
|
This will be assessed using a validated handgrip dynamometer
|
baseline
|
|
Handgrip strength
Time Frame: 1-month
|
This will be assessed using a validated handgrip dynamometer
|
1-month
|
|
Handgrip strength
Time Frame: 3-months
|
This will be assessed using a validated handgrip dynamometer
|
3-months
|
|
Handgrip strength
Time Frame: 6-months
|
This will be assessed using a validated handgrip dynamometer
|
6-months
|
|
60-second balance as assessed by the the Zibrio Stability Pro scale
Time Frame: Baseline
|
This is determined by the patient standing on the Zibrio Stability Pro Scale unassisted for one minute and will be measured on a scale of 1 to 9 with lower scores indicating higher risk of fall
|
Baseline
|
|
60-second balance as assessed by the the Zibrio Stability Pro scale
Time Frame: 1-month
|
This is determined by the patient standing on the Zibrio Stability Pro Scale unassisted for one minute and will be measured on a scale of 1 to 9 with lower scores indicating higher risk of fall
|
1-month
|
|
60-second balance as assessed by the the Zibrio Stability Pro scale
Time Frame: 3-months
|
This is determined by the patient standing on the Zibrio Stability Pro Scale unassisted for one minute and will be measured on a scale of 1 to 9 with lower scores indicating higher risk of fall
|
3-months
|
|
60-second balance as assessed by the the Zibrio Stability Pro scale
Time Frame: 6-months
|
This is determined by the patient standing on the Zibrio Stability Pro Scale unassisted for one minute and will be measured on a scale of 1 to 9 with lower scores indicating higher risk of fall
|
6-months
|
|
walking gait speed
Time Frame: Baseline
|
Gait speed will be assessed over a 6-meter distance measured within a private clinic space.
The participant will be instructed to walk at their normal walking pace (as if they were walking throughout the house) and the distance/time will be converted to meters/second.Faster walking speed is related to reduced fall-risk, improved physical function, and greater survival .
|
Baseline
|
|
walking gait speed
Time Frame: 1-month
|
Gait speed will be assessed over a 6-meter distance measured within a private clinic space.
The participant will be instructed to walk at their normal walking pace (as if they were walking throughout the house) and the distance/time will be converted to meters/second.Faster walking speed is related to reduced fall-risk, improved physical function, and greater survival .
|
1-month
|
|
walking gait speed
Time Frame: 3-months
|
Gait speed will be assessed over a 6-meter distance measured within a private clinic space.
The participant will be instructed to walk at their normal walking pace (as if they were walking throughout the house) and the distance/time will be converted to meters/second.Faster walking speed is related to reduced fall-risk, improved physical function, and greater survival .
|
3-months
|
|
walking gait speed
Time Frame: 6-months
|
Gait speed will be assessed over a 6-meter distance measured within a private clinic space.
The participant will be instructed to walk at their normal walking pace (as if they were walking throughout the house) and the distance/time will be converted to meters/second.Faster walking speed is related to reduced fall-risk, improved physical function, and greater survival .
|
6-months
|
|
Blood level of pro-collagen type 1 N-telopeptide (P1NP)
Time Frame: Baseline
|
P1NP is a metabolic marker of bone formation, indicates status of bone loss and a stable or decreased level will be indicating improved metabolism
|
Baseline
|
|
Blood level of pro-collagen type 1 N-telopeptide (P1NP)
Time Frame: 6 months
|
P1NP is a metabolic marker of bone formation, indicates status of bone loss and a stable or decreased level will be indicating improved metabolism
|
6 months
|
|
Frailty as assessed by the Fried criteria
Time Frame: Baseline
|
This consists of 5 items (unintentional weight loss, weakness [low grip strength], slowness low, self-reported exhaustion and low physical activity).
Patients who meet 1or 2 of the criteria are described as pre-frail and 3 or more as frail.
|
Baseline
|
|
Frailty as assessed by the Fried criteria
Time Frame: 1-month
|
This consists of 5 items (unintentional weight loss, weakness [low grip strength], slowness low, self-reported exhaustion and low physical activity).
Patients who meet 1or 2 of the criteria are described as pre-frail and 3 or more as frail.
|
1-month
|
|
Frailty as assessed by the Fried criteria
Time Frame: 3-months
|
This consists of 5 items (unintentional weight loss, weakness [low grip strength], slowness low, self-reported exhaustion and low physical activity).
Patients who meet 1or 2 of the criteria are described as pre-frail and 3 or more as frail.
|
3-months
|
|
Frailty as assessed by the Fried criteria
Time Frame: 6-months
|
This consists of 5 items (unintentional weight loss, weakness [low grip strength], slowness low, self-reported exhaustion and low physical activity).
Patients who meet 1or 2 of the criteria are described as pre-frail and 3 or more as frail.
|
6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nahid Rianon, MBBS, DrPH, The University of Texas Health Science Center, Houston
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 (Estimated)
January 1, 2025
Primary Completion (Estimated)
March 31, 2026
Study Completion (Estimated)
September 30, 2026
Study Registration Dates
First Submitted
November 1, 2024
First Submitted That Met QC Criteria
November 1, 2024
First Posted (Estimated)
November 4, 2024
Study Record Updates
Last Update Posted (Estimated)
November 4, 2024
Last Update Submitted That Met QC Criteria
November 1, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC-MS-24-0485
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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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