The Utility of MIndfulness-based Physical Exercise Program (MIPE Program) for Community-dwelling Older People With Sarcopenia: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this pilot randomized controlled trial (RCT) is to assess the feasibility, acceptability, and the preliminary effects of the MIndfulness-based Physical Exercise (MIPE) intervention among community-dwelling older people with sarcopenia. The main questions are: 1) is the MIPE intervention feasible and acceptable in older adults with sarcopenia? 2) is the MIPE intervention effective to improve the adherence to physical exercise intervention, alleviate the symptoms of sarcopenia and enhance the psychological well-being of older adults with sarcopenia? To answer these questions, a MIPE intervention protocol was developed by Delphi approach and end-users' evaluation. This pilot RCT will be conducted to assess the feasibility, acceptability, and the preliminary effects of the MIPE intervention. In the parallel-group, pilot RCT, 60 community-dwelling older people aged 60 years or older diagnosed with sarcopenia will be randomized into either the intervention group receiving the MIPE intervention 2 sessions weekly over 12 weeks or the control group receiving health educations. Each session of the MIPE intervention will last about 70 minutes, including 20-min mindfulness-based intervention, 40-min physical exercise (10-min warm-up, 20-min RE, and 10-min cool down) and 10-20-min sharing and discussion. The feasibility, acceptability and preliminary effectiveness on sarcopenia symptoms and psychological well-being of the MIPE program will be assessed.
详细描述
Background Sarcopenia is a geriatric syndrome characterised by low muscle mass, muscle strength, and physical function. Physical exercise (PE), especially resistance exercise, has demonstrated potential effects on sarcopenia. However, low motivation for regular PE is always reported as a major barrier in this population. Based on the PRIME (Plans, Responses, Impulses, Motives, and Evaluations) theory of motivation, Plan (i.e., well-planned, and evidence-based PE protocol), Motives (anticipated pleasure, satisfaction, and relief) and self-awareness on the present moment are the key points of human motivation and the potential targets to change a behaviour (i.e., adhering to a PE intervention) in older people with sarcopenia. Limited study on sarcopenia consisted of any interventional element to emphasise motives and self-awareness on the present moment, two key points of human motivation in the PRIME theory of motivation, although older people with sarcopenia are more likely to have negative feelings (i.e., fatigue, depress, anxiety) and experiences (i.e., derailed by daily life and distracted by concerns on PE). Mindfulness-based intervention (MBI) is a psychosocial intervention which aims to increase the participants' awareness of the present moment non-judgmentally. Increased evidence has indicated that MBI can also improve the levels of PE and adherence to PE interventions. Based on the mindful coping model, the positive relationship between mindfulness and PE might be that MBI has the potential to improve motivation for PE by addressing three key points of human motivation in the PRIME theory of motivation (focusing on the present moment, evoking positive feelings, and increasing self-awareness). Thus, MBI has the potential to be integrated into PE training to increase motivation and adherence to PE in older people with sarcopenia.
To address the above research gaps, we first conducted a SR on the home-based interventions among community-dwelling older people with sarcopenia was conducted, showing that home-based resistance exercise is feasible, suitable and has potential effects on sarcopenia, but few studies consisted of motivation-enhancing component. Then a Delphi study was conducted to develop the MIndfulness-based Physical Exercise (MIPE) intervention on this population. However, the feasibility, acceptability, and effects of the HOME intervention among community-dwelling older people with sarcopenia need to be explored.
Objective The objective of this study is to assess the feasibility, acceptability, and the preliminary effects of the MIPE intervention among community-dwelling older people with sarcopenia.
Methods A pilot randomised controlled trial (RCT) will be conducted to assess the feasibility, acceptability, and the preliminary effects of the HOME intervention. In the parallel-group, pilot RCT, 60 community-dwelling older people aged 60 years or older diagnosed with sarcopenia will be randomised into either the intervention group receiving the HOME intervention 2 sessions weekly over 12 weeks or the control group receiving health educations. Each session of the HOME intervention will last about 70 minutes, including 20-min MBI, 40-min HBE (10-min warm-up, 20-min RE, and 10-min cool down) and 10-20-min sharing and discussion. The feasibility of this programme will be determined by time spent recruiting participants, eligibility rate and recruitment rate. The acceptability of the HOME program will be assessed by: 1) prospective acceptability: recruitment rate and reasons for not involving in this study; 2) concurrent acceptability: attendance rate, complete rate, attrition rate and reasons for discontinuing; and 3) retrospective acceptability: the participants' perspectives on the intervention after taking part. Based on our conceptual framework, primary outcomes (muscle mass, muscle strength and physical function) and secondary outcomes (motivation, depressive symptoms, psychological well-being, mindfulness level and quality of life) will be assessed at baseline (T0), immediately post-intervention week 12 (T1) and 12 weeks after completion of the intervention. The quantitative data will be analysed by generalised estimating equations. The qualitative data will be Brun and Clark's thematic approach.
Impact and significance The MIPE program, consisting MBI and PE, is novel in the research field related to sarcopenia, which addresses the limitations of previous studies. This study has the potential to improve the symptoms of sarcopenia, the motivation and adherence to PE as well as the psychological health of this population, which finally improves the holistic welling of this population and facilitates their "ageing in place". For researchers, this study provides a relatively new sub-area in this field by generating insights on the importance of the above factors and the potential effectiveness of the mindfulness-based PE. For health professionals, the study provides a potentially effective way to improve the motivation and adherence to PE to treat sarcopenia.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the character of the intervention and control group in this study (the mindfulness-based PE vs health education), it is impossible to blind participants. The interventionist (the qualified mindfulness instructor and sport coach) is also unrealizable to be blinded. To reduce the allocation bias as much as possible, the following personnel will be blinded: the research assistants who are responsible for the participants recruitment, the research assistants who perform the randomization and the assessor who collect data.
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
- •Community-dwelling people aged 60 years or older
- •Diagnosed with sarcopenia by the criteria of the Asian Working Group for Sarcopenia (AWGS):
- •decreased muscle strength: handgrip strength of males < 28 kg; handgrip strength of females < 18 kg;
- •or decreased physical performance: the time of 5-time chair stand test ≥12 s;
- •or decreased muscle mass: SMI of males is < 7.0 kg/m2; SMI of females is < 5.7 kg/m2
- •Able to communicate and written and understand the instruction
排除标准
- •Been hospitalized for more than 5 days in the preceding 3 months
- •Unable to have body composition test, such as having heart pacemaker, vascular stent, steel plates and nails in the body
- •Contraindications to exercise, such as severe musculoskeletal disorders, severe cardiovascular diseases or spinal nerve injury
- •Having regular exercise: 150-minute moderate-intensity activity or 75-minute vigorous-intensity activity per week, with each session lasting at least 10 min in the past 3 months based on self-reported time and a self-perceived intensity via Borg Scale
- •Practicing mindfulness/yoga for >45 min a week in the 6 months prior to recruitment
结局指标
主要结局
Recruitment rate
时间窗: baseline (T0)
The recruitment rate will be calculated by the number of participants recruited/ the number of eligible participants. The higher recruitment rate indicates the higher willingness of the eligible participants to join the MIPE program.
Attendance rate
时间窗: week 12 (T1)
The attendance rate will be calculated by the attended sessions of the participants/ all sessions. The higher attendance rate roughly indicates the higher involvement of the participants in the MIPE program.
Complete rate
时间窗: week 12 (T1)
The complete rate will be calculated by the sessions that finished at least 80% / all attended sessions. The higher complete rate indicates the actual involvement of the participants in the MIPE program.
Eligibility rate
时间窗: baseline (T0)
The eligibility rate will be calculated by the number of eligible participants/the number of screened participants. The higher eligibility indicates the more potential participants.
Attrition rate
时间窗: week 12 (T1)
The attrition rate will be calculated by the number of participants dropped out total number of participants. If the participants engage in less than 80% of online sessions will be considered as attrition. The higher attrition rate indicates the lower participation in the MIPE program.
Time spent recruiting participants
时间窗: baseline (T0)
The time spent recruiting participants is the period from the first day of recruiting participants to the last day of recruiting participants. This outcome will help us understand the feasibility of the MIPE program. Specifically, shorter time spent recruiting participants roughly reflects the higher feasibility of the MIPE program.
The participants' perspectives on the intervention
时间窗: week 12 (T1)
The participants' perspectives on the intervention will be explored by individual interviews. There are mainly five questions in the individual interviews: 1) Generally, what do you think of this intervention? 2) What do you think of the content of this intervention? 3) What do you think of the frequency, duration and delivery mode of this intervention? 4) How about your motivation to exercise? 5) What recommendations do you have for this intervention? The results will help us to further revise and improve the MIPE to be more tailored to the older adults with sarcopenia. The individual interviews will be conducted by the PhD student who has received rigor trained in qualitative study methods and engaged in individual interviews before and a professor who has rich experience in conducting individual interviews and is familiar with sarcopenia and mindfulness.
次要结局
- The Chinese version of Five Facet Mindfulness Questionnaire (FFMQ-15-C)(baseline (T0) and week 12 (T1, immediately post-intervention))
- Handgrip strength(baseline (T0) and week 12 (T1, immediately post-intervention))
- The Chinese Version of the Physical Activity Scale for the Elderly (PASE-C)(baseline (T0) and week 12 (T1, immediately post-intervention))
- Skeletal muscle mass index(baseline (T0) and week 12 (T1, immediately post-intervention))
- The Chinese version of the short form Geriatric Depression Scale (GDS-15)(baseline (T0) and week 12 (T1, immediately post-intervention))
- The Chinese version of the Behavioral Regulation in Exercise Questionnaire-2 (C-BREQ-2)(baseline (T0) and week 12 (T1, immediately post-intervention))
- The Chinese version of Sarcopenia and Quality of life (SarQoL®)(baseline (T0) and week 12 (T1, immediately post-intervention))
- 5-times Chair stand test(baseline (T0) and week 12 (T1, immediately post-intervention))
- The Chinese version of Raff's Psychological Well-being Scale (RPWS-C)(baseline (T0) and week 12 (T1, immediately post-intervention))
研究者
Patrick KOR Pui Kin
Assistant Professor
The Hong Kong Polytechnic University