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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Frailty status
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dual-task training program (Other)
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.
干预措施: Resistance exercise (Other)
结局指标
主要结局
Frailty status
时间窗: 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
时间窗: 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).
Feasibility and acceptability
时间窗: 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
时间窗: 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.
Frailty Status
时间窗: 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).
次要结局
- Cognitive function(Baseline (Week 0) and Post-treatment (Week 10))
- Pain level(Baseline (Week 0) and Post-treatment (Week 10))
- Health-related quality of life(Baseline (Week 0) and Post-treatment (Week 10))
- Cognitive function(Baseline (Week 0) and Post-treatment (Week 10))
- Health-related quality of life(Baseline (Week 0) and Post-treatment (Week 10))
- Pain level(Baseline (Week 0) and Post-treatment (Week 10))
研究者
YAU King Wai Derek
Assistant Professor
The Hong Kong Polytechnic University