Effects of Exergames and Resistance Training

Sponsor

Hong Kong Metropolitan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05920577

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty Sacropenia Cognition Mood Mobility	Other: exergames and resistance training Other: Resistance training	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This pilot randomised controlled trial will conduct in a nursing home starting from Aug 2023 in Hong KongThis pilot randomised controlled trial will conduct in a nursing home starting from Aug 2023 in Hong Kong

Masking:

Single (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.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exergames and resistance training group Participants will receive exergaming and resistance training programme over a period of 12 weeks	Other: exergames and resistance training 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.
Active Comparator: Resistance training group Participants will receive resistance training programme over a period of 12 weeks	Other: Resistance training 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.

Arm

Intervention/Treatment

Experimental: Exergames and resistance training group

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

Other: exergames and resistance training

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.

Active Comparator: Resistance training group

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

Other: Resistance training

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Cognitive function, higher score means better cognitive function [T1: baseline (before the study begins)]
Will be assessed using the Montreal Cognitive Assessment (HK version)
Change from baseline cognitive function at 6 weeks [T2: mid-intervention (week 6)]
Will be assessed using the Montreal Cognitive Assessment (HK version)
Change from baseline cognitive function at 12 weeks [T3: post-intervention (week 12)]
Will be assessed using the Montreal Cognitive Assessment (HK version)
Change from baseline cognitive function at 16 weeks [T4: 1 month follow up (week 16)]
Will be assessed using the Montreal Cognitive Assessment (HK version)
Change from baseline cognitive function at 24 weeks [T5: 3 months follow up (week 24)]
Will be assessed using the Montreal Cognitive Assessment (HK version)
Mobility, longer time means worse funcitonal mobility [T1: baseline (before the study begins)]
Will be assessed using the Timed Up and Go Test
Change from baseline mobility at 6 weeks [T2: mid-intervention (week 6)]
Will be assessed using the Timed Up and Go Test
Change from baseline mobility at 12 weeks [T3: post-intervention (week 12)]
Will be assessed using the Timed Up and Go Test
Change from baseline mobility at 16 weeks [T4: 1 month follow up (week 16)]
Will be assessed using the Timed Up and Go Test
Change from baseline mobility at 24 weeks [T5: 3 months follow up (week 24)]
Will be assessed using the Timed Up and Go Test
Frailty, score range 0 to 9, higher score means higher level of frailty [T1: baseline (before the study begins)]
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Change from baseline frailty at 6 weeks [T2: mid-intervention (week 6)]
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Change from baseline frailty at 12 weeks [T3: post-intervention (week 12)]
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Change from baseline frailty at 16 weeks [T4: 1 month follow up (week 16)]
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)
Change from baseline frailty at 24 weeks [T5: 3 months follow up (week 24)]
Will be assessed using the Chinese version of Clinical Frailty Scale (CFS-C)

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hong Kong Metropolitan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Liu Tai Wa, Associate Professor, Hong Kong Metropolitan University

ClinicalTrials.gov Identifier:

NCT05920577

Other Study ID Numbers:

Frailty_2023

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr Liu Tai Wa, Associate Professor, Hong Kong Metropolitan University

Nursing home residents

Frailty

Sacropenia

Additional relevant MeSH terms:

Frailty

Study Results

No Results Posted as of Jun 27, 2023