NCT05920577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

June 17, 2023

Last Update Submit

September 14, 2025

Conditions

Keywords

Nursing home residentsFrailtySacropenia

Outcome Measures

Primary Outcomes (15)

  • 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, higher score means better muscle quantity

    Will be assessed using a bioelectrical impedance measurement

    T2: mid-intervention (week 6)

  • 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)

  • 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)

  • 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)

  • 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, higher score means better muscle strength

    Will be assessed using a handheld dynamometer

    T2: mid-intervention (week 6)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (20)

  • Cognitive function, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition

    T1: baseline (before the study begins)

  • Change from baseline cognitive function at 6 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition

    T2: mid-intervention (week 6)

  • Change from baseline cognitive function at 12 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition

    T3: post-intervention (week 12)

  • Change from baseline cognitive function at 16 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition

    T4: 1 month follow up (week 16)

  • Change from baseline cognitive function at 24 weeks, higher score means better cognitive function, score ranged from 0 - 30, higher scores mean better cognition

    T5: 3 months follow up (week 24)

  • +15 more secondary outcomes

Study Arms (2)

Exergames and resistance training group

EXPERIMENTAL

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

Other: exergames and resistance training

Resistance training group

ACTIVE COMPARATOR

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

Other: Resistance training

Interventions

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.

Exergames and resistance training group

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.

Resistance training group

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jockey club Institute of Health

Ho Man Tin, Hong Kong

Location

MeSH Terms

Conditions

Frailty

Interventions

ExergamingResistance Training

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This pilot randomised controlled trial will conduct in a nursing home starting from Aug 2023 in Hong Kong
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 17, 2023

First Posted

June 27, 2023

Study Start

April 1, 2024

Primary Completion

December 31, 2024

Study Completion

May 30, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations