Clinical trial NCT05920577: 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
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Sacropenia
Cognition
Mood
Mobility
Keywords: Nursing home residents
Frailty
Sacropenia
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot randomised controlled trial will conduct in a nursing home starting from Aug 2023 in Hong Kong
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Muscle quantity, higher score means better muscle quantity
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline muscle quantity at 6 weeks, higher score means better muscle quantity
timeFrame: T2: mid-intervention (week 6)
measure: Change from baseline muscle quantity at 12 weeks, higher score means better muscle quantity
timeFrame: T3: post-intervention (week 12)
measure: Change from baseline muscle quantity at 16 weeks, higher score means better muscle quantity
timeFrame: T4: 1 month follow up (week 16)
measure: Change from baseline muscle quantity at 24 weeks, higher score means better muscle quantity
timeFrame: T5: 3 months follow up (week 24)
measure: Muscle strength, higher score means better muscle strength
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline muscle strength at 6 weeks, higher score means better muscle strength
timeFrame: T2: mid-intervention (week 6)
measure: Change from baseline muscle strength at 12 weeks, higher score means better muscle strength
timeFrame: T3: post-intervention (week 12)
measure: Change from baseline muscle strength at 16 weeks, higher score means better muscle strength
timeFrame: T4: 1 month follow up (week 16)
measure: Change from baseline muscle strength at 24 weeks, higher score means better muscle strength
timeFrame: T5: 3 months follow up (week 24)
measure: Lower Extremity functions, score ranged from 0-12, higher scores mean better lower extremity functions
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline lower extremity functions at 6 weeks, score ranged from 0-12, higher scores mean better lower extremity functions
timeFrame: T2: mid-intervention (week 6)
measure: Change from baseline lower extremity functions at 12 weeks, score ranged from 0-12, higher scores mean better lower extremity functions
timeFrame: T3: post-intervention (week 12)
measure: Change from baseline lower extremity functions at 16 weeks, score ranged from 0-12, higher scores mean better lower extremity functions
timeFrame: T4: 1 month follow up (week 16)
measure: Change from baseline lower extremity functions at 24 weeks, score ranged from 0-12, higher scores mean better lower extremity functions
timeFrame: T5: 3 months follow up (week 24)
Secondary outcomes:
measure: Cognitive function, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline cognitive function at 6 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition
timeFrame: T2: mid-intervention (week 6)
measure: Change from baseline cognitive function at 12 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition
timeFrame: T3: post-intervention (week 12)
measure: Change from baseline cognitive function at 16 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition
timeFrame: T4: 1 month follow up (week 16)
measure: Change from baseline cognitive function at 24 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition
timeFrame: T5: 3 months follow up (week 24)
measure: Mobility, longer time means worse functional mobility
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline mobility at 6 weeks, longer time means worse functional mobility
timeFrame: T2: mid-intervention (week 6)
measure: Change from baseline mobility at 12 weeks, longer time means worse functional mobility
timeFrame: T3: post-intervention (week 12)
measure: Change from baseline mobility at 16 weeks, longer time means worse functional mobility
timeFrame: T4: 1 month follow up (week 16)
measure: Change from baseline mobility at 24 weeks, longer time means worse functional mobility
timeFrame: T5: 3 months follow up (week 24)
measure: Frailty, score range 0 to 9, higher score means higher level of frailty
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline frailty at 6 weeks, score range 0 to 9, higher score means higher level of frailty
timeFrame: T2: mid-intervention (week 6)
measure: Change from baseline frailty at 12 weeks, score range 0 to 9, higher score means higher level of frailty
timeFrame: T3: post-intervention (week 12)
measure: Change from baseline frailty at 16 weeks, score range 0 to 9, higher score means higher level of frailty
timeFrame: T4: 1 month follow up (week 16)
measure: Change from baseline frailty at 24 weeks, score range 0 to 9, higher score means higher level of frailty
timeFrame: T5: 3 months follow up (week 24)
measure: Sarcopenia, score ranged from 0 to 20, lower score means lower risk
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline sarcopenia at 6 weeks, score ranged from 0 to 20, lower score means lower risk
timeFrame: T2: mid-intervention (week 6)
measure: Change from baseline sarcopenia at 12 weeks, score ranged from 0 to 20, lower score means lower risk
timeFrame: T3: post-intervention (week 12)
measure: Change from baseline sarcopenia at 16 weeks, score ranged from 0 to 20, lower score means lower risk
timeFrame: T4: 1 month follow up (week 16)
measure: Change from baseline sarcopenia at 24 weeks, score ranged from 0 to 20, lower score means lower risk
timeFrame: T5: 3 month follow up (week 16)
Other outcomes:
Locations:
city: Ho Man Tin
country: Hong Kong
facility: Jockey club Institute of Health
Study officials:
References: