- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06849557
Chair-bound Exergaming in Pre-frail/ Frail Older Adults in Nursing Home
Effectiveness of Chair-bound Exergaming on Physical and Cognitive Functions in Pre-frail/ Frail Older Adults in Nursing Home: A Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective To explore the effects of the chair-bound exergaming on the enjoyment of physical activity in in pre-frail/ frail nursing home residents.
To evaluate the effects of the chair-bound exergaming in improving physical and cognitive function in pre-frail/ frail nursing home residents.
Research plan and methodology Thirty nursing home residents will be recruited from the nursing homes.
All the eligible participant will be randomly allocated to either one of the following 2 groups (i) Exergaming (intervention group), or (ii) wait list control.
- Intervention group (exergaming group, ERG) Those allocated to the ERG will receive supervised chair-bound exercise programme for 12 weeks.
- Control group (wait list control, CG) Those allocated to the CG will receive supervised chair-bound exercise programme for 12 weeks after post-assessment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bonny YM Wong
- Phone Number: +852 3970-2976
- Email: bymwong@hkmu.edu.hk
Study Locations
-
-
-
Kowloon, Hong Kong
- Recruiting
- Hiu Kwong (Tak Yue) Nursing Centre
-
Contact:
- Leung
- Phone Number: 2367 8918
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- older adults aged 60 years or older living in the nursing homes;
- pre-frail or frail according to the Fried Frailty Phenotypes;
- ability to understand and execute instructions; and
- ability to sit unassisted on a chair or in a wheelchair.
Exclusion Criteria:
- no controlled medical diagnosed of severe cardiometabolic, respiratory and musculoskeletal disorders;
- any conditions that hinder the participation of intervention and assessment; and
- being involved in any other clinical trials.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Wait-list Control
Wait list control, after post-test, 12 week supervised exercise intervention
|
|
|
Experimental: Exergaming
12-week exergaming intervention
|
This intervention will last 12 weeks.
Frail/ pre-frail participants will engage in supervised chair-bound exergaming.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
upper extremity endurance
Time Frame: T0: baseline
|
upper extremity endurance measured by arm curl test
|
T0: baseline
|
|
upper extremity endurance
Time Frame: T1: 6 week
|
upper extremity endurance measured by arm curl test
|
T1: 6 week
|
|
upper extremity endurance
Time Frame: T2: immediately (1 week) after intervention
|
upper extremity endurance measured by arm curl test
|
T2: immediately (1 week) after intervention
|
|
enjoyment
Time Frame: T0: baseline
|
enjoyment of physical activity measured by Physical Activity Enjoyment Scale (PACES)
|
T0: baseline
|
|
enjoyment
Time Frame: T1: 6 week
|
enjoyment of physical activity measured by Physical Activity Enjoyment Scale (PACES)
|
T1: 6 week
|
|
enjoyment
Time Frame: T2: immediately (1 week) after intervention
|
enjoyment of physical activity measured by Physical Activity Enjoyment Scale (PACES)
|
T2: immediately (1 week) after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
upper extremity strength
Time Frame: T0: baseline
|
upper extremity strength measured by handheld dynamometer
|
T0: baseline
|
|
lung capacity
Time Frame: T0: baseline
|
lung capacity measured by peak flow meter
|
T0: baseline
|
|
sitting balance
Time Frame: T0: baseline
|
sitting balance measured by sitting with opened eyes, sitting with closed eyes, sitting with shaking "no" and sitting with lifted leg
|
T0: baseline
|
|
mental health
Time Frame: T0: baseline
|
mental health measured by Patient Health Questionnaire-4 (PHQ-4), range: 0-12; higher score indicates more psychological distress
|
T0: baseline
|
|
cognitive function
Time Frame: T0: baseline
|
cognitive function measured by Montreal Cognitive Assessment (MoCA), range: 0-30; lower score indicates more cognitive impairment.
|
T0: baseline
|
|
upper extremity strength
Time Frame: T1: 6 week
|
upper extremity strength measured by handheld dynamometer
|
T1: 6 week
|
|
upper extremity strength
Time Frame: T2: immediately (1 week) after intervention
|
upper extremity strength measured by handheld dynamometer
|
T2: immediately (1 week) after intervention
|
|
lung capacity
Time Frame: T1: 6 week
|
lung capacity measured by peak flow meter
|
T1: 6 week
|
|
lung capacity
Time Frame: T2: immediately (1 week) after intervention
|
lung capacity measured by peak flow meter
|
T2: immediately (1 week) after intervention
|
|
sitting balance
Time Frame: T1: 6 week
|
sitting balance measured by sitting with opened eyes, sitting with closed eyes, sitting with shaking "no" and sitting with lifted leg
|
T1: 6 week
|
|
sitting balance
Time Frame: T2: immediately (1 week) after intervention
|
sitting balance measured by sitting with opened eyes, sitting with closed eyes, sitting with shaking "no" and sitting with lifted leg
|
T2: immediately (1 week) after intervention
|
|
feasibility, acceptability and appropriateness of intervention
Time Frame: T2: immediately (1 week) after intervention
|
feasibility, acceptability and appropriateness of intervention measured by questionnaire
|
T2: immediately (1 week) after intervention
|
|
mental health
Time Frame: T1: 6 week
|
mental health measured by Patient Health Questionnaire-4 (PHQ-4), range: 0-12; higher score indicates more psychological distress
|
T1: 6 week
|
|
mental health
Time Frame: T2: immediately (1 week) after intervention
|
mental health measured by Patient Health Questionnaire-4 (PHQ-4), range: 0-12; higher score indicates more psychological distress
|
T2: immediately (1 week) after intervention
|
|
cognitive function
Time Frame: T1: 6 week
|
cognitive function measured by Montreal Cognitive Assessment (MoCA), range: 0-30; lower score indicates more cognitive impairment.
|
T1: 6 week
|
|
cognitive function
Time Frame: T2: immediately (1 week) after intervention
|
cognitive function measured by Montreal Cognitive Assessment (MoCA), range: 0-30; lower score indicates more cognitive impairment.
|
T2: immediately (1 week) after intervention
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE-SF2024/58
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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