MIndfulness-based Physical Exercise Program (MIPE Program) on Sarcopenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Utility of MIndfulness-based Physical Exercise Program (MIPE Program) for Community-dwelling Older People With Sarcopenia: a Pilot Randomised Controlled Trial

Conditions
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Sarcopenia

Intervention / Treatment
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* Other: mindfulness-based phsycial exercise intervention
* Other: health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mindfulness-based physical exercie<br>The participants will receive about 70-min MIPE program twice a week, which will be conducted in a hybrid way, a combination of face-to-face and at home by a qualified mindfulness therapist and a sport coach. | Other: mindfulness-based phsycial exercise intervention<br>* The intervention is 12 weeks, two times a week. The MIPE intervention will be conducted in a hybrid way, a combination of face-to-face and at home, by a qualified mindfulness therapist and a qualified sport coach. Specifically, the participants will attend the face-to-face sessions once every two weeks and in other weeks, they will perform the intervention at home using videos and templates. The face-to-face sessions will be conducted at the health care centre. The intervention of each session will include 1) introduce the theme of this session, 2) mini lectures about the theme; 3) mindfulness practice related to the theme; 4) tips of keeping mindfulness during PE; 5) warm up: lead with mindfulness words; 6) resistance exercise; 7) cool down: lead with mindfulness words; 8) discussion.<br>|
| Placebo Comparator: Health education<br>Health education consisting of discussion provided by a registered nurse will be conducted as a control of socialization and interaction. | Other: health education<br>* The number of sessions, duration, frequency, group size and delivery modality will be similar to the intervention group. The topics of the health education are the care of common diseases in the older adults, including hypertension, diabetes, osteoporosis, COPD, dementia, depression. Each session is about 70 min (same as intervention group), including 10-20 min lecture and 50-60 discussion and sharing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent recruiting participants | 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. | baseline (T0) | 
| Eligibility rate | 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. | baseline (T0) | 
| Recruitment rate | 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. | baseline (T0) | 
| Attendance rate | 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. | week 12 (T1) | 
| Complete rate | 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. | week 12 (T1) | 
| Attrition rate | 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. | week 12 (T1) | 
| The participants' perspectives on the intervention | 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. | week 12 (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle mass index | Skeletal muscle mass index (SMI) will be assessed by Bioelectrical impedance analysis (Inbody 270, Korea). The procedure of testing is below: before the test, the participants will be required to remove every item that might influence the test, such as metal keys, bank cards, mobile phones, from their body, and then take off their shoes and socks. Then, they will be instructed to stand straight on the detector with two hands holding the handles of the detector for about one minute. During the testing, they will be not allowed to talk, move, or laugh. Higher Skeletal muscle mass index (SMI) means the higher muscle mass. Comparisons of changes of skeletal muscle mass index (SMI) will be considered as follows: baseline (T0)- week 12 (T1). | baseline (T0) and week 12 (T1, immediately post-intervention) | 
| The Chinese version of the Behavioral Regulation in Exercise Questionnaire-2 (C-BREQ-2) | The Chinese version of the Behavioral Regulation in Exercise Questionnaire-2 (C-BREQ-2) assesses the motivation of the participants to exercise. The C-BREQ-2 is a self-report measure with 18-items and each item is rated on a 5-point Likert scale from 0 to 4, with a higher score indicating higher motivation to exercise. Comparison of change of the C-BREQ-2 will be considered as follows: baseline (T0)- week 12 (T1). | baseline (T0) and week 12 (T1, immediately post-intervention) | 
| The Chinese version of the short form Geriatric Depression Scale (GDS-15) | The Chinese version of the short form Geriatric Depression Scale (GDS-15) assesses the depressive symptoms of the participants. The score of GDS ranges 0-15 with each no answers of item 1,5,7 and 11 scoring 1 while the rest items scoring 1 with yes answers. The classification of depressive symptoms based on the score is: score 0-4: normal; score 5-8: mild depression; score 9-11: moderate depression; score 12-15: severe depression. Comparison of change of the Chinese version of the GDS-15 will be considered as follows: baseline (T0)- week 12 (T1). | baseline (T0) and week 12 (T1, immediately post-intervention) | 
| The Chinese version of Raff's Psychological Well-being Scale (RPWS-C) | The Chinese version of Raff's Psychological Well-being Scale (RPWS-C) assesses the psychological well-being of the participants. The RPWS-C has 24 items, and each item is rated from 1 (strongly disagree) to 6 (strongly agree), with higher score indicating higher psychological well-being. Comparison of change of the RPWS-C will be considered as follows: baseline (T0)- week 12 (T1). | baseline (T0) and week 12 (T1, immediately post-intervention) | 
| The Chinese Version of the Physical Activity Scale for the Elderly (PASE-C) | The Chinese Version of the Physical Activity Scale for the Elderly (PASE-C) assesses the physical activity level of the participants. The PASE-C, consisting of 10-items, is a self-reported scale to measure the occupational, household, and leisure activities for the last seven days. Higher score of the PASE-C indicates higher physical activity. Comparison of change of the PASE-C will be considered as follows: baseline (T0)- week 12 (T1). | baseline (T0) and week 12 (T1, immediately post-intervention) | 
| The Chinese version of Five Facet Mindfulness Questionnaire (FFMQ-15-C) | The Chinese version of Five Facet Mindfulness Questionnaire (FFMQ-15-C) assesses the mindfulness level of the participants. The FFMQ-15-C has 15 items and each item is rated on a 5-point Likert scale, ranging from1 = never or very rarely true to 5 = very often or always true, with higher total scores indicating a higher degree of mindfulness. Comparison of change of the FFMQ-15-C will be considered as follows: baseline (T0)- week 12 (T1). | baseline (T0) and week 12 (T1, immediately post-intervention) | 
| The Chinese version of Sarcopenia and Quality of life (SarQoL®) | The Chinese version of Sarcopenia and Quality of life (SarQoL®) assesses the quality of life of the participants. The SarQoL® has 22 items with higher score indicating higher quality of life. Comparison of change of the SarQoL® will be considered as follows: baseline (T0)- week 12 (T1). | baseline (T0) and week 12 (T1, immediately post-intervention) | 
| Handgrip strength | Handgrip strength will be measured by Jamar dynamometer (Jamar, 563213, USA) and the method refers to the recommendation of American Society of Hand Therapists. Comparisons of changes of handgrip strength will be considered as follows: baseline (T0)- week 12 (T1). | baseline (T0) and week 12 (T1, immediately post-intervention) | 
| 5-times Chair stand test | 5-times Chair stand test reflects the physical function and is an indicator in the sarcopenia diagnosis. The participants will be invited to stand and sit from a chair (about 43 cm) five times and the time will be recorded. Short time of the test, better physical function. Comparisons of changes of 5-times Chair stand test will be considered as follows: baseline (T0)- week 12 (T1). | baseline (T0) and week 12 (T1, immediately post-intervention) |