Effects of Exergames and Resistance Training

Frailty Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920577
• Other study ID #: Frailty_2023
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Hong Kong Metropolitan University
• Contact: Liu Tai Wa, PhD
• Phone: 00852 39708714
• Email: twliu[@]hkmu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognition
• Frailty
• Mobility
• Mood

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Jockey club Institute of Health	Ho Man Tin

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Metropolitan University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle quantity, higher score means better muscle quantity	Will be assessed using a bioelectrical impedance measurement	T1: baseline (before the study begins)
Primary	Change from baseline muscle quantity at 6 weeks, higher score means better muscle quantity	Will be assessed using a bioelectrical impedance measurement	T2: mid-intervention (week 6)
Primary	Change from baseline muscle quantity at 12 weeks, higher score means better muscle quantity	Will be assessed using a bioelectrical impedance measurement	T3: post-intervention (week 12)
Primary	Change from baseline muscle quantity at 16 weeks, higher score means better muscle quantity	Will be assssed using a bioelectrical impedance measurement	T4: 1 month follow up (week 16)
Primary	Change from baseline muscle quantity at 24 weeks, higher score means better muscle quantity	Will be assssed using a bioelectrical impedance measurement	T5: 3 months follow up (week 24)
Primary	Muscle strength, higher score means better muscle strength	Will be assessed using a handheld dynamometer	T1: baseline (before the study begins)
Primary	Change from baseline muscle strength at 6 weeks, higher score means better muscle strength	Will be assessed using a handheld dynamometer	T2: mid-intervention (week 6)
Primary	Change from baseline muscle strength at 12 weeks, higher score means better muscle strength	Will be assessed using a handheld dynamometer	T3: post-intervention (week 12)
Primary	Change from baseline muscle strength at 16 weeks, higher score means better muscle strength	Will be assessed using a handheld dynamometer	T4: 1 month follow up (week 16)
Primary	Change from baseline muscle strength at 24 weeks, higher score means better muscle strength	Will be assessed using a handheld dynamometer	T5: 3 months follow up (week 24)
Primary	Lower Extremity functions, score ranged from 0-12, higher scores mean better lower extremity functions	Will be assessed using the Short Physical Performance Battery	T1: baseline (before the study begins)
Primary	Change from baseline lower extremity functions at 6 weeks, score ranged from 0-12, higher scores mean better lower extremity functions	Will be assessed using the Short Physical Performance Battery	T2: mid-intervention (week 6)
Primary	Change from baseline lower extremity functions at 12 weeks, score ranged from 0-12, higher scores mean better lower extremity functions	Will be assessed using the Short Physical Performance Battery	T3: post-intervention (week 12)
Primary	Change from baseline lower extremity functions at 16 weeks, score ranged from 0-12, higher scores mean better lower extremity functions	Will be assessed using the Short Physical Performance Battery	T4: 1 month follow up (week 16)
Primary	Change from baseline lower extremity functions at 24 weeks, score ranged from 0-12, higher scores mean better lower extremity functions	Will be assessed using the Short Physical Performance Battery	T5: 3 months follow up (week 24)
Secondary	Cognitive function, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition	Will be assessed using the Montreal Cognitive Assessment (HK version)	T1: baseline (before the study begins)
Secondary	Change from baseline cognitive function at 6 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition	Will be assessed using the Montreal Cognitive Assessment (HK version)	T2: mid-intervention (week 6)
Secondary	Change from baseline cognitive function at 12 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition	Will be assessed using the Montreal Cognitive Assessment (HK version)	T3: post-intervention (week 12)
Secondary	Change from baseline cognitive function at 16 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition	Will be assessed using the Montreal Cognitive Assessment (HK version)	T4: 1 month follow up (week 16)
Secondary	Change from baseline cognitive function at 24 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition	Will be assessed using the Montreal Cognitive Assessment (HK version)	T5: 3 months follow up (week 24)
Secondary	Mobility, longer time means worse functional mobility	Will be assessed using the Timed Up and Go Test	T1: baseline (before the study begins)
Secondary	Change from baseline mobility at 6 weeks, longer time means worse functional mobility	Will be assessed using the Timed Up and Go Test	T2: mid-intervention (week 6)
Secondary	Change from baseline mobility at 12 weeks, longer time means worse functional mobility	Will be assessed using the Timed Up and Go Test	T3: post-intervention (week 12)
Secondary	Change from baseline mobility at 16 weeks, longer time means worse functional mobility	Will be assessed using the Timed Up and Go Test	T4: 1 month follow up (week 16)
Secondary	Change from baseline mobility at 24 weeks, longer time means worse functional mobility	Will be assessed using the Timed Up and Go Test	T5: 3 months follow up (week 24)
Secondary	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)
Secondary	Change from baseline frailty at 6 weeks, 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)	T2: mid-intervention (week 6)
Secondary	Change from baseline frailty at 12 weeks, 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)	T3: post-intervention (week 12)
Secondary	Change from baseline frailty at 16 weeks, 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)	T4: 1 month follow up (week 16)
Secondary	Change from baseline frailty at 24 weeks, 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)	T5: 3 months follow up (week 24)
Secondary	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)
Secondary	Change from baseline sarcopenia at 6 weeks, 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)	T2: mid-intervention (week 6)
Secondary	Change from baseline sarcopenia at 12 weeks, 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)	T3: post-intervention (week 12)
Secondary	Change from baseline sarcopenia at 16 weeks, 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)	T4: 1 month follow up (week 16)
Secondary	Change from baseline sarcopenia at 24 weeks, 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)	T5: 3 month follow up (week 16)