AzTrials
AzTrials

Chronic Musculoskeletal PainNCT07035327

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

A study testing Dual-task training program and Resistance exercise in people with Chronic Musculoskeletal Pain and Frailty, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Chronic Musculoskeletal Pain, Frailty
What is being tested?
Dual-task training program and Resistance exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteHong Kong
Study dates
1 Jul 2025to 31 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • PolyU Institutional Review Board, The Hong Kong Polytechnic University

    Hong Kong

Other trials in Hong Kong

About this study

Official 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

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.

Being tested
Dual-task training program, Resistance exercise
Keywords
Chronic musculoskeletal pain, Frailty, Dual-task training, Pain management
Medical subject headings
Frailty, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual-task training programOther

    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 exerciseOther

    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.

Study groups in NCT07035327
Study groupRoleWhat they receive
Intervention group - Dual-task training programExperimentalParticipants 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.
Receives: Other: Dual-task training program
Control group - Resistance exerciseActive comparatorSubjects 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.
Receives: Other: Resistance exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility and acceptability

    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.

    Measured: Post-treatment (Week 10)

  2. Frailty status

    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).

    Measured: Baseline (Week 0) and Post-treatment (Week 10)

  3. Frailty Status

    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).

    Measured: Baseline (Week 0) and Post-treatment (Week 10)

  4. Frailty status

    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.

    Measured: Baseline (Week 0) and Post-treatment (Week 10)

Secondary outcomes (5)

  1. Cognitive function

    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.

    Measured: Baseline (Week 0) and Post-treatment (Week 10)

  2. Cognitive function

    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.

    Measured: Baseline (Week 0) and Post-treatment (Week 10)

  3. Cognitive function

    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.

    Measured: Baseline (Week 0) and Post-treatment (Week 10)

  4. Pain level

    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).

    Measured: Baseline (Week 0) and Post-treatment (Week 10)

  5. Health-related quality of life

    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.

    Measured: Baseline (Week 0) and Post-treatment (Week 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2025
  2. Study start1 Jul 2025
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07035327
Sponsor's protocol ID
HSEARS20250310005
Status last verified
Dec 2025
First submitted
5 Jun 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Borg, G. (1998). Borg's Perceived Exertion and Pain Scales. Champaign, IL: Human Kinetics.

  • Liguori, G., Feito, Y., Fountaine, C. (Charles J., & Roy, B. (Eds.). (2022). ACSM's guidelines for exercise testing and prescription (Eleventh edition.). Wolters Kluwer.

  • Zhou, Y., Chen, J., Liu, Y., Wang, P., Zhu, L., & Yan, T. (2016). Validity and Reliability of the Cognitive Failures Questionnaire in Chinese College Students. Chinese Journal of Clinical Psychology, 24(3), 438-443.

  • Frankenberg, C., Weiner, J., Knebel, M., Abulimiti, A., Toro, P., Herold, C. J., Schultz, T., & Schröder, J. (2021). Verbal fluency in normal aging and cognitive decline: Results of a longitudinal study. Computer Speech & Language, 68, 101195-. https://doi.org/10.1016/j.csl.2021.101195

  • Winser S, Pang MYC, Rauszen JS, Chan AYY, Chen CH, Whitney SL. Does integrated cognitive and balance (dual-task) training improve balance and reduce falls risk in individuals with cerebellar ataxia? Med Hypotheses. 2019 May;126:149-153. doi: 10.1016/j.mehy.2019.03.001. Epub 2019 Mar 5.

    PubMed 31010491

  • Tiecker, A. P., Cadore, E. L., Izquierdo, M., Zmuda, G. G. O., Aguirre, F. B., & Bós, Â. J. G. (2024). Acceptability of a home-based multicomponent exercise program (Vivifrail®) for the oldest-old via videoconferencing during the Covid-19 pandemic. Revista Brasileira de Geriatria e Gerontologia., 27. https://doi.org/10.1590/1981-22562024027.230089.en

  • Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

    PubMed 8126356

  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PubMed 11253156

  • Auyeung TW, Lee JS, Leung J, Kwok T, Woo J. The selection of a screening test for frailty identification in community-dwelling older adults. J Nutr Health Aging. 2014;18(2):199-203. doi: 10.1007/s12603-013-0365-4.

    PubMed 24522474

  • Wong EL, Cheung AW, Wong AY, Xu RH, Ramos-Goni JM, Rivero-Arias O. Normative Profile of Health-Related Quality of Life for Hong Kong General Population Using Preference-Based Instrument EQ-5D-5L. Value Health. 2019 Aug;22(8):916-924. doi: 10.1016/j.jval.2019.02.014. Epub 2019 Jul 27.

    PubMed 31426933

  • Wong A, Xiong YY, Kwan PW, Chan AY, Lam WW, Wang K, Chu WC, Nyenhuis DL, Nasreddine Z, Wong LK, Mok VC. The validity, reliability and clinical utility of the Hong Kong Montreal Cognitive Assessment (HK-MoCA) in patients with cerebral small vessel disease. Dement Geriatr Cogn Disord. 2009;28(1):81-7. doi: 10.1159/000232589. Epub 2009 Aug 11.

    PubMed 19672065

  • Varela-Vasquez LA, Minobes-Molina E, Jerez-Roig J. Dual-task exercises in older adults: A structured review of current literature. J Frailty Sarcopenia Falls. 2020 Jun 1;5(2):31-37. doi: 10.22540/JFSF-05-031. eCollection 2020 Jun.

    PubMed 32510028

  • Sugimoto T, Arai H, Sakurai T. An update on cognitive frailty: Its definition, impact, associated factors and underlying mechanisms, and interventions. Geriatr Gerontol Int. 2022 Feb;22(2):99-109. doi: 10.1111/ggi.14322. Epub 2021 Dec 9.

    PubMed 34882939

  • Simao R, Lemos A, Salles B, Leite T, Oliveira E, Rhea M, Reis VM. The influence of strength, flexibility, and simultaneous training on flexibility and strength gains. J Strength Cond Res. 2011 May;25(5):1333-8. doi: 10.1519/JSC.0b013e3181da85bf.

    PubMed 21386731

  • Salse-Batan J, Gonzalez-Devesa D, Dunabeitia I, Bidaurrazaga-Letona I, Ayan-Perez C, Sanchez-Lastra MA. Effects of stretching exercise on walking performance and balance in older adults: A systematic review and meta-analysis. Geriatr Nurs. 2025 Jan-Feb;61:479-490. doi: 10.1016/j.gerinurse.2024.12.018. Epub 2024 Dec 28.

    PubMed 39733629

Questions about this trial

What is this clinical trial studying?

A study testing Dual-task training program and Resistance exercise in people with Chronic Musculoskeletal Pain and Frailty, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and acceptability (time frame: Post-treatment (Week 10)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07035327, which also lists 43 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in