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Effects of Exergames and Resistance Training

Primary Purpose

Frailty, Sacropenia, Cognition

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
exergames and resistance training
Resistance training
Sponsored by
Hong Kong Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring Nursing home residents, Frailty, Sacropenia

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: living in a nursing home fulfilled 1, 2 or 3 Fried Criteria of frailty score ≥7 of 10 on the Chinese version of the Abbreviated Mental Test able to follow the instructions of assessment and intervention Exclusion Criteria: involved in any drug or other clinical trials having any additional medical conditions (such as epilepsy) unable to walk independently without the use of walking aids having any other conditions that will hinder the assessment and intervention (e.g.,visual/audio impairment could not be corrected by glasses/hearing aids etc).

Sites / Locations

  • Jockey club Institute of HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exergames and resistance training group

Resistance training group

Arm Description

Participants will receive exergaming and resistance training programme over a period of 12 weeks

Participants will receive resistance training programme over a period of 12 weeks

Outcomes

Primary Outcome Measures

Muscle quantity, higher score means better muscle quantity
Will be assessed using a bioelectrical impedance measurement
Change from baseline muscle quantity at 6 weeks
Will be assessed using a bioelectrical impedance measurement
Change from baseline muscle quantity at 12 weeks
Will be assessed using a bioelectrical impedance measurement
Change from baseline muscle quantity at 16 weeks
Will be assssed using a bioelectrical impedance measurement
Change from baseline muscle quantity at 24 weeks
Will be assssed using a bioelectrical impedance measurement
Muscle strength, higher score means better muscle strength
Will be assessed using a handheld dynamometer
Change from baseline muscle strength at 6 weeks
Will be assessed using a handheld dynamometer
Change from baseline muscle strength at 12 weeks
Will be assessed using a handheld dynamometer
Change from baseline muscle strength at 16 weeks
Will be assessed using a handheld dynamometer
Change from baseline muscle strength at 24 weeks
Will be assessed using a handheld dynamometer
Lower Extremity functions, higher scores mean better lower extremity functions
Will be assessed using the Short Physical Performance Battery
Change from baseline lower extremity functions at 6 weeks
Will be assessed using the Short Physical Performance Battery
Change from baseline lower extremity functions at 12 weeks
Will be assessed using the Short Physical Performance Battery
Change from baseline lower extremity functions at 16 weeks
Will be assessed using the Short Physical Performance Battery
Change from baseline lower extremity functions at 24 weeks
Will be assessed using the Short Physical Performance Battery

Secondary Outcome Measures

Cognitive function, higher score means better cognitive function
Will be assessed using the Montreal Cognitive Assessment (HK version)
Change from baseline cognitive function at 6 weeks
Will be assessed using the Montreal Cognitive Assessment (HK version)
Change from baseline cognitive function at 12 weeks
Will be assessed using the Montreal Cognitive Assessment (HK version)
Change from baseline cognitive function at 16 weeks
Will be assessed using the Montreal Cognitive Assessment (HK version)
Change from baseline cognitive function at 24 weeks
Will be assessed using the Montreal Cognitive Assessment (HK version)
Mobility, longer time means worse funcitonal mobility
Will be assessed using the Timed Up and Go Test
Change from baseline mobility at 6 weeks
Will be assessed using the Timed Up and Go Test
Change from baseline mobility at 12 weeks
Will be assessed using the Timed Up and Go Test
Change from baseline mobility at 16 weeks
Will be assessed using the Timed Up and Go Test
Change from baseline mobility at 24 weeks
Will be assessed using the Timed Up and Go Test
Frailty, score range 0 to 9, higher score means higher level of frailty
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Change from baseline frailty at 6 weeks
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Change from baseline frailty at 12 weeks
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Change from baseline frailty at 16 weeks
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Change from baseline frailty at 24 weeks
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Sarcopenia, score ranged from 0 to 20, lower score means lower risk
Will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls(SARC-Calf)
Change from baseline sarcopenia at 6 weeks
Will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls (SARC-Calf)
Change from baseline sarcopenia at 12 weeks
Will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls(SARC-Calf)
Change from baseline sarcopenia at 16 weeks
Will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls (SARC-Calf)
Change from baseline sarcopenia at 24 weeks
Will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls (SARC-Calf)

Full Information

First Posted
June 17, 2023
Last Updated
September 25, 2023
Sponsor
Hong Kong Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT05920577
Brief Title
Effects of Exergames and Resistance Training
Official Title
Effects of the Combined Use of Exergaming and Resistance Training in Improving the Frailty of Nursing Home Residents: A Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Frailty is a common geriatric condition with significantly increased vulnerability to stress and susceptibility of negative health-related outcomes. Sacropenia and impaired cognitive function are two major contributors to frailty. This study aims to evaluate the effects of the combined use of exergaming and resistance training in improving the frailty of nursing home residents.
Detailed Description
Frailty is a common geriatric condition with significantly increased vulnerability to stress and susceptibility of negative health-related outcomes. The prevalence rates of frailty varies across countries, and the pooled estimates of prevalence rates of 52.3% and 40.2% of frailty and prefrailty were reported among nursing home residents respectively. Previous studies also revealed that frailty is predictive for various adverse health outcomes. Sacropenia is a major etiologic risk factor to frailty. It refers to an age-related generalised muscle disorder featuring with loss of muscle mass and function5. Talar et al systematically reviewed and meta-analysed 25 randomised controlled trials (RCTs) using resistance training among 2,267 older people (age >65 years) with pre-sarcopenia, sarcopenia, pre-frailty or frailty. It was revealed that, compared to control, resistance training with at least 8 weeks intervention period had small to large effects in improving handgrip strength, lower-limb strength, agility, gait speed, postural stability, functional performance, fat mass and muscle [Effect size (ES) = 0.29 - 0.93, p <0.001 to = 0.007]. Cognitive impairment is another major risk factor for declined frailty status among prefrail older people. Non-frail older people are known to have better performance on cognitive status, including processing speed, executive function, attention and working memory, immediate memory and delayed memory (g = 0.320 to 0.64), than frail older people. Ample research evidence suggested that cognition predicts the incidence of frailty. Exergaming is a fast growing research trend in gerontechnology and several commercial exergaming consoles, such as the Xbox system (including Xbox One and Xbox 360) and Nintendo Will (Wii Sports and Wii Fit), are available. Ogawa et al systematically reviewed 7 clinical trials (5 RCTs and 2 uncontrolled studies) and revealed that exergaming could improve cognitive functions, including executive function, process speed and reaction time, of older people. Moreover, a recent RCT revealed that, compared with the combined use of exercise (resistance, aerobic and balance training), a 12 week Kinect-based exergaming could better improve the global cognition [F(1, 44) = 5.277, p = 0.026] as measured by the Montreal Cognitive Assessment of community-frail older people. The Kinect-based group (n = 25) also demonstrated significant improvement in verbal (p < 0.05) and working (p < 0.05) memory post-intervention but the combined exercise group (n = 21) did not. Given that sacropenia and impaired cognitive function are 2 major contributors to frailty; and exergaming and resistance training are effective treatments in improving the cognitive function and sacropenia of older people respectively, this study aims to evaluate the effects of the combined use of exergaming and resistance training in improving the frailty of nursing home residents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Sacropenia, Cognition, Mood, Mobility
Keywords
Nursing home residents, Frailty, Sacropenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This pilot randomised controlled trial will conduct in a nursing home starting from Aug 2023 in Hong Kong
Masking
Outcomes Assessor
Masking Description
After the baseline assessment, all eligible participants will be allocated randomly in a 1:1 ratio to either (1) experimental group which received exergaming and resistance training over a period of 12 weeks, or (2) control group which received resistance training over a period of 12 weeks. The research assistant, who is responsible for allocation, is independent from the data collection and anslysis, and the intervention. The participants will be reminded not to disclose information related to group allocation to the assessors to prevent possible bias during measurement. All assessments will be performed by an assessor who is blinded to the group allocation and not involved in the delivery of the intervention.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exergames and resistance training group
Arm Type
Experimental
Arm Description
Participants will receive exergaming and resistance training programme over a period of 12 weeks
Arm Title
Resistance training group
Arm Type
Active Comparator
Arm Description
Participants will receive resistance training programme over a period of 12 weeks
Intervention Type
Other
Intervention Name(s)
exergames and resistance training
Intervention Description
In each session, the participants will receive 40 minutes of combined use of exergaming and resistance training. The participants will practice the exergames using the gaming system Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan). The gaming software "Nintendo Switch Sports" will be adopted in which arrays of exergames are available to strengthen both the upper and lower extremity muscle and improve the balance ability of participants. The exergaming programme will consist of both upper (badminton game and tennis game) and lower (soccer game) extremity games. For week 1 and 2, the participants will first practice 1-minute warm up exercise (stretching exercises) and then the 3 exergames. For week 3 to 12, the participants will receive the same warm up exercise and exergames as if week 1 and 2 but there will be an addition of light cuff weight for resistance training.
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
The resistance training programme consists of 2 parts, the upper limb and lower limb resistance exercises. For the upper limb resistance exercises, the participants will first practice 5-minute warm up of upper limb using ergometer and then undergo 2 resistance exercises, including handgrip and elbow flexion. For the lower limb exercise, the participants will also first practice 5-minute warm up of lower limb using ergometer and then undergo 3 resistance exercises, including squatting, single-leg standing and knee extension.
Primary Outcome Measure Information:
Title
Muscle quantity, higher score means better muscle quantity
Description
Will be assessed using a bioelectrical impedance measurement
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline muscle quantity at 6 weeks
Description
Will be assessed using a bioelectrical impedance measurement
Time Frame
T2: mid-intervention (week 6)
Title
Change from baseline muscle quantity at 12 weeks
Description
Will be assessed using a bioelectrical impedance measurement
Time Frame
T3: post-intervention (week 12)
Title
Change from baseline muscle quantity at 16 weeks
Description
Will be assssed using a bioelectrical impedance measurement
Time Frame
T4: 1 month follow up (week 16)
Title
Change from baseline muscle quantity at 24 weeks
Description
Will be assssed using a bioelectrical impedance measurement
Time Frame
T5: 3 months follow up (week 24)
Title
Muscle strength, higher score means better muscle strength
Description
Will be assessed using a handheld dynamometer
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline muscle strength at 6 weeks
Description
Will be assessed using a handheld dynamometer
Time Frame
T2: mid-intervention (week 6)
Title
Change from baseline muscle strength at 12 weeks
Description
Will be assessed using a handheld dynamometer
Time Frame
T3: post-intervention (week 12)
Title
Change from baseline muscle strength at 16 weeks
Description
Will be assessed using a handheld dynamometer
Time Frame
T4: 1 month follow up (week 16)
Title
Change from baseline muscle strength at 24 weeks
Description
Will be assessed using a handheld dynamometer
Time Frame
T5: 3 months follow up (week 24)
Title
Lower Extremity functions, higher scores mean better lower extremity functions
Description
Will be assessed using the Short Physical Performance Battery
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline lower extremity functions at 6 weeks
Description
Will be assessed using the Short Physical Performance Battery
Time Frame
T2: mid-intervention (week 6)
Title
Change from baseline lower extremity functions at 12 weeks
Description
Will be assessed using the Short Physical Performance Battery
Time Frame
T3: post-intervention (week 12)
Title
Change from baseline lower extremity functions at 16 weeks
Description
Will be assessed using the Short Physical Performance Battery
Time Frame
T4: 1 month follow up (week 16)
Title
Change from baseline lower extremity functions at 24 weeks
Description
Will be assessed using the Short Physical Performance Battery
Time Frame
T5: 3 months follow up (week 24)
Secondary Outcome Measure Information:
Title
Cognitive function, higher score means better cognitive function
Description
Will be assessed using the Montreal Cognitive Assessment (HK version)
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline cognitive function at 6 weeks
Description
Will be assessed using the Montreal Cognitive Assessment (HK version)
Time Frame
T2: mid-intervention (week 6)
Title
Change from baseline cognitive function at 12 weeks
Description
Will be assessed using the Montreal Cognitive Assessment (HK version)
Time Frame
T3: post-intervention (week 12)
Title
Change from baseline cognitive function at 16 weeks
Description
Will be assessed using the Montreal Cognitive Assessment (HK version)
Time Frame
T4: 1 month follow up (week 16)
Title
Change from baseline cognitive function at 24 weeks
Description
Will be assessed using the Montreal Cognitive Assessment (HK version)
Time Frame
T5: 3 months follow up (week 24)
Title
Mobility, longer time means worse funcitonal mobility
Description
Will be assessed using the Timed Up and Go Test
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline mobility at 6 weeks
Description
Will be assessed using the Timed Up and Go Test
Time Frame
T2: mid-intervention (week 6)
Title
Change from baseline mobility at 12 weeks
Description
Will be assessed using the Timed Up and Go Test
Time Frame
T3: post-intervention (week 12)
Title
Change from baseline mobility at 16 weeks
Description
Will be assessed using the Timed Up and Go Test
Time Frame
T4: 1 month follow up (week 16)
Title
Change from baseline mobility at 24 weeks
Description
Will be assessed using the Timed Up and Go Test
Time Frame
T5: 3 months follow up (week 24)
Title
Frailty, score range 0 to 9, higher score means higher level of frailty
Description
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline frailty at 6 weeks
Description
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Time Frame
T2: mid-intervention (week 6)
Title
Change from baseline frailty at 12 weeks
Description
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Time Frame
T3: post-intervention (week 12)
Title
Change from baseline frailty at 16 weeks
Description
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Time Frame
T4: 1 month follow up (week 16)
Title
Change from baseline frailty at 24 weeks
Description
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Time Frame
T5: 3 months follow up (week 24)
Title
Sarcopenia, score ranged from 0 to 20, lower score means lower risk
Description
Will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls(SARC-Calf)
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline sarcopenia at 6 weeks
Description
Will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls (SARC-Calf)
Time Frame
T2: mid-intervention (week 6)
Title
Change from baseline sarcopenia at 12 weeks
Description
Will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls(SARC-Calf)
Time Frame
T3: post-intervention (week 12)
Title
Change from baseline sarcopenia at 16 weeks
Description
Will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls (SARC-Calf)
Time Frame
T4: 1 month follow up (week 16)
Title
Change from baseline sarcopenia at 24 weeks
Description
Will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls (SARC-Calf)
Time Frame
T5: 3 month follow up (week 16)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: living in a nursing home fulfilled 1, 2 or 3 Fried Criteria of frailty score ≥7 of 10 on the Chinese version of the Abbreviated Mental Test able to follow the instructions of assessment and intervention Exclusion Criteria: involved in any drug or other clinical trials having any additional medical conditions (such as epilepsy) unable to walk independently without the use of walking aids having any other conditions that will hinder the assessment and intervention (e.g.,visual/audio impairment could not be corrected by glasses/hearing aids etc).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Tai Wa, PhD
Phone
00852 39708714
Email
twliu@hkmu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Candy Leung
Phone
00852 27686251
Email
chileung@hkmu.edu.hk
Facility Information:
Facility Name
Jockey club Institute of Health
City
Ho Man Tin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu TW, PhD
Phone
39708714

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The datasets of the study will only be available from the corresponding author on reasonable request after the findings being published in peer-reviewed journal.

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Effects of Exergames and Resistance Training

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