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Completed

NCT Number: NCT07035327

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PolyU Institutional Review Board, The Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dual-task training program

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.

Resistance Exercise

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.

Primary outcomes

  1. 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.

  2. 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).
  3. 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).
  4. 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.

Secondary outcomes

  1. 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.
  2. 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.
  3. 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.
  4. 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).
  5. 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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