- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06912607
Exercise Program for Deaf Seniors to Increase Their Balance and Fitness
Balance and Fitness Enhancement Program for Deaf Older Adults
Deaf older adults 60 years and older are enrolled into an 8-week exercise program delivered in American Sign Language. The class meets twice a week, with handout and video homework.
Outcome measures are self-reported balance confidence, lower extremity strength, walking and agility, and standing balance. In addition, attendance and keeping up with exercises at home will be tracked.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The intervention will be 8 weeks of 2 meetings/wk exercise class, delivered entirely in ASL.
Homework exercise will also be provided.
10-12 participants will be recruited for each of the 4 semesters of offerings.
Physical balance as well as balance confidence will be measured prior to and immediately after the 8-week intervention. In addition, balance confidence will be measured 6-months after the conclusion of the intervention period.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20002
- Gallaudet University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- Deaf
- Uses American Sign Language (ASL) fluently
- Community-dwelling
- Able to walk independently for at least 20 ft
- Willing to attend classes twice a week at Gallaudet University
Exclusion Criteria:
- Blindness
- Dementia
- Neurological conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Single Group
Deaf older adults.
|
8 weeks of 2 meetings/wk exercise class, with a once weekly homework exercise, delivered entirely in ASL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sit-to-Stand
Time Frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
|
The number of times a person can stand from a chair and sit down, without using hands.
|
1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
|
|
Timed Up-and-Go
Time Frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
|
The time it takes for a person to stand from a chair, walk 10 ft, turn around, walk back, and sit back down.
|
1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
|
|
Modified Clinical Test of Sensory Integration on Balance
Time Frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
|
The measure of how steadily a person can stand under 4 conditions (eyes open, on firm surface, eyes closed on firm surface, eyes open on foam, and eyes closed on foam)
|
1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
|
|
Sit and Reach
Time Frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
|
How far a person can reach beyond their toes.
Measure of flexibility.
|
1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
|
|
Activities-specific Balance Confidence scale
Time Frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention, 6 months after intervention
|
A self-report measure of how confident a person is in not falling under various conditions.
Reported in 0-100%; higher score means more confidence (better outcome).
|
1 - 21 days before the start of intervention; within 2 weeks of the end of intervention, 6 months after intervention
|
|
Fall Risk Questionnaire
Time Frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention, 6 months after intervention
|
A self-report measure of the number of risk factors a person exhibits.
Reported in a scale of 0-14 points; higher score indicates a greater risk (worse outcome).
|
1 - 21 days before the start of intervention; within 2 weeks of the end of intervention, 6 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance rate
Time Frame: During intervention
|
How many exercise class sessions, out of 16, a participant attended
|
During intervention
|
|
Step Count
Time Frame: During intervention
|
The number of steps gathered through Fitbit
|
During intervention
|
|
Effective exercise level
Time Frame: During intervention
|
The Active Zone Minutes gathered through Fitbit
|
During intervention
|
|
Self-reported exercise level
Time Frame: 6 months after the intervention
|
The participant's report on how much time they are spending on exercises
|
6 months after the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chizuko Tamaki, AuD, PhD, Gallaudet University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY24-34
- 1R15AG087454-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Fall
-
University of AmsterdamCompletedDeprescribing | Fall | Fall Injury | Fall Patients | Accidental FallNetherlands
-
Betul Esra CevikCompletedAccidental Fall | Fall Prevention | Fall Risk FactorsTurkey (Türkiye)
-
Brown UniversityNot yet recruitingFall | Fall Prevention | Fall Injury Prevention
-
University of Illinois at Urbana-ChampaignUnknownFall Injury | Fall Prevention | Fall Safety
-
University of ArizonaVirginia Polytechnic Institute and State UniversityNot yet recruiting
-
Neuroscience Research AustraliaThe University of New South WalesCompleted
-
Aalborg University HospitalCompleted
-
Massachusetts General HospitalCricoCompletedFall Injury | Fall PatientsUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...VU University of AmsterdamNot yet recruitingFall | Aged | Fall Injury | Fall Patients | Polypharmacy | Accidental Fall | Aged, 80 and Over | DeprescriptionsNetherlands
-
Cairo UniversityNot yet recruitingFall Risk, Fall PreventionEgypt
Clinical Trials on Balance in Motion Exercise class
-
University of ManitobaUnknown
-
Alzheimer's Disease Cooperative Study (ADCS)National Institute on Aging (NIA); Wake Forest University Health SciencesCompletedMild Cognitive Impairment | Cognitive Decline | Memory ImpairmentUnited States
-
University of British ColumbiaUnknownBrain Injuries, Traumatic | Cerebrovascular Trauma | Acute Brain InjuriesCanada
-
University of LisbonCompletedAmyotrophic Lateral Sclerosis
-
Lawson Health Research InstituteCanadian Institutes of Health Research (CIHR)Completed
-
Azienda Ospedaliero-Universitaria CareggiNot yet recruitingClass III Malocclusion | Dentofacial Anomalies, Including Malocclusion
-
Centre Hospitalier Universitaire de NiceCompleted
-
Dartmouth-Hitchcock Medical CenterParkinson's Disease FoundationTerminatedParkinson's DiseaseUnited States
-
University of ArizonaQatar National Research Foundation, QatarUnknown
-
Institute of Technology, SligoSligo General HospitalCompleted