Dual-task Training for Frail Older Adults With Chronic Musculoskeletal Pain (Pilot)

NCT ID: NCT07035327

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-10-31

Brief Summary

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The goal of this clinical trial is to investigate the feasibility and effect of a 10-week dual-task training program on frailty status in community-dwelling older adults with frailty and chronic musculoskeletal pain.

Main question: Is a 10-week dual-task training program, that combines resistance and cognitive training, feasible and accepted by community-dwelling older adults who have frailty and chronic musculoskeletal pain, and what is the effect of a 10-week dual-task training program on the frailty status in community-dwelling older adults who have frailty and chronic musculoskeletal pain?

Participants will attend supervised training sessions (either dual-task training \[Intervention group\] or resistance exercise \[Control group\]) for 10 weeks.

Detailed Description

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Conditions

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Chronic Musculoskeletal Pain Frailty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Randomization and group assignment will be performed by an investigator not involved in recruitment or assessment. After participants' eligibility for enrolment is confirmed, a researcher will use a computer to automatically generate a random sequence using Excel software (Microsoft Corporation, Redmond, USA) to generate random integers, with odd numbers being the experimental group and even numbers being the control group. The grouping information will be stored in a separate folder. Participants will undergo the corresponding exercise program which will be supervised by the researcher. The outcome assessor will be blinded to the treatment allocation.

Study Groups

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Intervention group - Dual-task training program

Participants in the intervention group will engage in a dual-task training program, in which resistance training will be incorporated with cognitive tasks (2 sessions per week for 10 weeks consecutively). The training sessions will take place in an academic institution under the guidance and supervision from the members of research team.

Group Type EXPERIMENTAL

Dual-task training program

Intervention Type OTHER

Participants in the intervention group will engage in a dual-task training program, in which resistance training will be incorporated with cognitive tasks.

\- Resistance training: Participants will be instructed to perform the following exercises with proper form: (1) squat to chair, (2) seated unilateral hip flexion, (3) seated unilateral knee extension, (4) standing unilateral knee flexion and (5) bilateral calf raise. The lower limb exercises will be followed by four upper limb exercises: (6) seated elbow flexion, (7) twisting a towel, (8) seated horizontal opening of arms and elbow, (9) seated diagonal opening of arm and elbow.

\- Cognitive task: Subjects will be asked to perform a verbal fluency task or mental arithmetic tasks simultaneously with the resistance training exercises.

Control group - Resistance exercise

Subjects in the control group will perform the resistance exercises only (2 sessions per week for 10 weeks consecutively) without receiving any cognitive training. The training sessions will take place in an academic institution under the guidance and supervision from the members of our research team.

Group Type ACTIVE_COMPARATOR

Resistance exercise

Intervention Type OTHER

Subjects in the control group will perform the resistance exercises only without receiving any cognitive training. Ten-minute warm-up and cool-down sessions will precede and follow each exercise session.

Interventions

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Dual-task training program

Participants in the intervention group will engage in a dual-task training program, in which resistance training will be incorporated with cognitive tasks.

\- Resistance training: Participants will be instructed to perform the following exercises with proper form: (1) squat to chair, (2) seated unilateral hip flexion, (3) seated unilateral knee extension, (4) standing unilateral knee flexion and (5) bilateral calf raise. The lower limb exercises will be followed by four upper limb exercises: (6) seated elbow flexion, (7) twisting a towel, (8) seated horizontal opening of arms and elbow, (9) seated diagonal opening of arm and elbow.

\- Cognitive task: Subjects will be asked to perform a verbal fluency task or mental arithmetic tasks simultaneously with the resistance training exercises.

Intervention Type OTHER

Resistance exercise

Subjects in the control group will perform the resistance exercises only without receiving any cognitive training. Ten-minute warm-up and cool-down sessions will precede and follow each exercise session.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults, of either sex, aged 60 years or above,
* living in Hong Kong, being able to read and communicate verbally,
* screened frail using the Tilburg Frailty Indicator (TFI) (total score ≥5) with report of memory problems (question 9) (Gobbens et al., 2010),
* experiencing any CMP with a pain level higher or equal to 4 in the numerical pain rating scale over a consecutive 3-month period.

Exclusion Criteria

Any individuals with either of the following will be excluded:

* absence of frailty,
* surgical procedure in the lower limbs or the vertebral column;
* wheelchair bound or inability to walk for five minutes;
* severe balance impairment;
* uncompensated cardiac or vascular condition;
* acute inflammatory musculoskeletal conditions;
* ongoing cancer; dementia;
* neurological diseases such as stroke, Parkinson's disease, cerebellar disease, myelopathy, and peripheral neuropathy;
* mental illnesses such as schizophrenia, bipolar, psychosis, borderline personality disorder;
* illiteracy.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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YAU King Wai Derek

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derek Yau

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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PolyU Institutional Review Board, The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

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Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://vivifrail.com/wp-content/uploads/2019/11/VIVIFRAIL-ENG-Interactivo.pdf

Izquierdo, M., Casas-Herrero, A., Zambom-Ferraresi, F., Martínez-Velilla, N., Alonso-Bouzón, C., \& Rodriguez-Mañas, L. (2017). A practical guide for prescribing a multi-component physical training program to prevent weakness and falls in people over 70.

Other Identifiers

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HSEARS20250310005

Identifier Type: -

Identifier Source: org_study_id

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