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

December 3, 2025 updated by: YAU King Wai Derek, The Hong Kong Polytechnic University

Effect of the Resistance-cognitive Dual-task Training on Frailty Status and Cognitive Function in Frail Community-dwelling Older Adults With Chronic Musculoskeletal Pain: A Pilot Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • PolyU Institutional Review Board, The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty status
Time Frame: Baseline (Week 0) and Post-treatment (Week 10)

Measured by the Tilburg frailty indicator (TFI).

  • There are 15 items in total, with a score of 0 or 1 on each item. The total score ranges from 0 to 15 points. A higher score mean a worse outcome (Higher frailty level).
  • A total score of >/=5 has a validity of 0.86 to determine the frailty status of the community-dwelling older Chinese population (Dong et al., 2017).
Baseline (Week 0) and Post-treatment (Week 10)
Frailty Status
Time Frame: Baseline (Week 0) and Post-treatment (Week 10)

Measured by Fried Frailty Phenotype (FFP).

  • It consists of 5 components in assessing the severity of frailty, including weight loss, weakness, exhaustion, slowness and low physical activity, with a score of 0 or 1 for each component.
  • The total score ranges from 0 to 5 points. A higher score mean a worse outcome. The frailty status is categorized into robust (0), pre-frail (1-2), and frail (3-5).
Baseline (Week 0) and Post-treatment (Week 10)
Frailty status
Time Frame: Baseline (Week 0) and Post-treatment (Week 10)

Measured by Short Physical Performance Battery (SPPB).

  • The SPPB is an assessment tool for participants' physical function and can be used to show the physical frailty.
  • It includes 3 components: standing balance, 4-m gait speed, and five-repetition sit-to-stand motion. Each component has a score of 0-4. The total score ranges from 0 to 12 points. A higher score mean a worse outcome.
  • A total score of <9 is regarded as frail.
Baseline (Week 0) and Post-treatment (Week 10)
Feasibility and acceptability
Time Frame: Post-treatment (Week 10)
The primary outcomes will be feasibility and acceptability of the dual task training program. Feasibility will be evaluated through recruitment and compliance rates of the program. Recruitment rate will be defined as the total number of participants recruited out of the total number of participants screened. Treatment compliance will be defined as the proportion of scheduled sessions attended in each group. Acceptability will be assessed by a six-question post-program questionnaire based on the barriers to engaging in physical activity. Questions relating to perceived importance and satisfaction with the program, any discomfort felt during training, difficulty of the exercises, appropriateness of duration and usefulness on daily activity will be asked to rate from a 5-point Likert scale from 'Strongly disagree' to 'Strongly agree', and be collected at the end of the intervention.
Post-treatment (Week 10)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: Baseline (Week 0) and Post-treatment (Week 10)

Measured by Hong Kong version Montreal Cognitive Assessment (HK-MoCA).

  • The score ranges from 0 to 30 points. A higher score indicates better cognitive function.
  • A score of 25 or below may indicate the presence of mild cognitive impairment.
Baseline (Week 0) and Post-treatment (Week 10)
Cognitive function
Time Frame: Baseline (Week 0) and Post-treatment (Week 10)

Measured by forward digit span test.

  • Participants will be presented with a random series of digits and be asked to repeat them in the order presented.
  • A longer span indicates better working memory with high internal reliability.
Baseline (Week 0) and Post-treatment (Week 10)
Cognitive function
Time Frame: Baseline (Week 0) and Post-treatment (Week 10)

Measured by Cognitive failures questionnaire (CFQ) (Chinese version), a self-report measure to assess individual forgetfulness, distractibility, and false triggering in everyday life.

- It has 25 items (0-4 points). The total score ranges from 0 to 100 points. A higher point indicates fewer cognitive difficulties in daily life.
Baseline (Week 0) and Post-treatment (Week 10)
Pain level
Time Frame: Baseline (Week 0) and Post-treatment (Week 10)

The average pain score will be assessed by the Numerical Pain Rating Scale (NPRS).

  • Participants will be asked to rate the average pain level on a scale from 0 (no pain) to 10 (maximal pain).
  • A higher score mean a worse outcome (higher pain level).
Baseline (Week 0) and Post-treatment (Week 10)
Health-related quality of life
Time Frame: Baseline (Week 0) and Post-treatment (Week 10)

Measured by EuroQoL 5-Dimension 5-Level (EQ-5D-5L) (Hong Kong Chinese version) questionnaire.

  • The questionnaire consists of 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension will be rated from 1 (no problem) to 5 (extreme problems). A higher score mean a worse outcome.
  • It also has an EQ-VAS scale to self-rate the overall health perception from 0 (worst health) to 100 (best health). A higher score mean a better outcome.
Baseline (Week 0) and Post-treatment (Week 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Derek Yau, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

June 5, 2025

First Submitted That Met QC Criteria

June 15, 2025

First Posted (Actual)

June 25, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20250310005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only anonymised data will be shared to others when requested after publication is released. The anonymised data will be stored at the institutional data repository.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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