Effects of Exergames and Resistance Training

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of the Combined Use of Exergaming and Resistance Training in Improving the Frailty of Nursing Home Residents: A Pilot Randomised Controlled Trial

Conditions
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Sacropenia, Frailty, Cognition, Mood, Mobility

Intervention / Treatment
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* Other: exergames and resistance training
* Other: Resistance training


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This pilot randomised controlled trial will conduct in a nursing home starting from Aug 2023 in Hong Kong
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exergames and resistance training group<br>Participants will receive exergaming and resistance training programme over a period of 12 weeks | Other: exergames and resistance training<br>* 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.<br>|
| Active Comparator: Resistance training group<br>Participants will receive resistance training programme over a period of 12 weeks | Other: Resistance training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle quantity, higher score means better muscle quantity | Will be assessed using a bioelectrical impedance measurement | T1: baseline (before the study begins) | 
| Change from baseline muscle quantity at 6 weeks | Will be assessed using a bioelectrical impedance measurement | T2: mid-intervention (week 6) | 
| Change from baseline muscle quantity at 12 weeks | Will be assessed using a bioelectrical impedance measurement | T3: post-intervention (week 12) | 
| Change from baseline muscle quantity at 16 weeks | Will be assssed using a bioelectrical impedance measurement | T4: 1 month follow up (week 16) | 
| Change from baseline muscle quantity at 24 weeks | Will be assssed using a bioelectrical impedance measurement | T5: 3 months follow up (week 24) | 
| Muscle strength, higher score means better muscle strength | Will be assessed using a handheld dynamometer | T1: baseline (before the study begins) | 
| Change from baseline muscle strength at 6 weeks | Will be assessed using a handheld dynamometer | T2: mid-intervention (week 6) | 
| Change from baseline muscle strength at 12 weeks | Will be assessed using a handheld dynamometer | T3: post-intervention (week 12) | 
| Change from baseline muscle strength at 16 weeks | Will be assessed using a handheld dynamometer | T4: 1 month follow up (week 16) | 
| Change from baseline muscle strength at 24 weeks | Will be assessed using a handheld dynamometer | T5: 3 months follow up (week 24) | 
| Lower Extremity functions, higher scores mean better lower extremity functions | Will be assessed using the Short Physical Performance Battery | T1: baseline (before the study begins) | 
| Change from baseline lower extremity functions at 6 weeks | Will be assessed using the Short Physical Performance Battery | T2: mid-intervention (week 6) | 
| Change from baseline lower extremity functions at 12 weeks | Will be assessed using the Short Physical Performance Battery | T3: post-intervention (week 12) | 
| Change from baseline lower extremity functions at 16 weeks | Will be assessed using the Short Physical Performance Battery | T4: 1 month follow up (week 16) | 
| Change from baseline lower extremity functions at 24 weeks | Will be assessed using the Short Physical Performance Battery | T5: 3 months follow up (week 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function, higher score means better cognitive function | Will be assessed using the Montreal Cognitive Assessment (HK version) | T1: baseline (before the study begins) | 
| Change from baseline cognitive function at 6 weeks | Will be assessed using the Montreal Cognitive Assessment (HK version) | T2: mid-intervention (week 6) | 
| Change from baseline cognitive function at 12 weeks | Will be assessed using the Montreal Cognitive Assessment (HK version) | T3: post-intervention (week 12) | 
| Change from baseline cognitive function at 16 weeks | Will be assessed using the Montreal Cognitive Assessment (HK version) | T4: 1 month follow up (week 16) | 
| Change from baseline cognitive function at 24 weeks | Will be assessed using the Montreal Cognitive Assessment (HK version) | T5: 3 months follow up (week 24) | 
| Mobility, longer time means worse funcitonal mobility | Will be assessed using the Timed Up and Go Test | T1: baseline (before the study begins) | 
| Change from baseline mobility at 6 weeks | Will be assessed using the Timed Up and Go Test | T2: mid-intervention (week 6) | 
| Change from baseline mobility at 12 weeks | Will be assessed using the Timed Up and Go Test | T3: post-intervention (week 12) | 
| Change from baseline mobility at 16 weeks | Will be assessed using the Timed Up and Go Test | T4: 1 month follow up (week 16) | 
| Change from baseline mobility at 24 weeks | Will be assessed using the Timed Up and Go Test | T5: 3 months follow up (week 24) | 
| 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) | T1: baseline (before the study begins) | 
| Change from baseline frailty at 6 weeks | Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C) | T2: mid-intervention (week 6) | 
| Change from baseline frailty at 12 weeks | Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C) | T3: post-intervention (week 12) | 
| Change from baseline frailty at 16 weeks | Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C) | T4: 1 month follow up (week 16) | 
| Change from baseline frailty at 24 weeks | Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C) | T5: 3 months follow up (week 24) | 
| 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) | T1: baseline (before the study begins) | 
| 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) | T2: mid-intervention (week 6) | 
| 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) | T3: post-intervention (week 12) | 
| 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) | T4: 1 month follow up (week 16) | 
| 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) | T5: 3 month follow up (week 16) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing home residents, Frailty, Sacropenia