Chronic Musculoskeletal Pain, Frailty
Conditions
Keywords
Chronic musculoskeletal pain, Frailty, Dual-task training, Pain management
Brief 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. 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.
Interventions
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.
OTHERResistance 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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and acceptability | 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. |
| Frailty status | 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). |
| Frailty Status | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | 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. |
| Pain level | 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). |
| Health-related quality of life | 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. |
Countries
Hong Kong
Outcome results
None listed