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

NCT ID: NCT05982067

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2023-12-30

Brief Summary

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

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

mindfulness-based physical exercie

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.

Group Type: EXPERIMENTAL

mindfulness-based phsycial exercise intervention

Intervention Type: OTHER

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.

Health education

Health education consisting of discussion provided by a registered nurse will be conducted as a control of socialization and interaction.

Group Type: PLACEBO_COMPARATOR

health education

Intervention Type: OTHER

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.

Interventions

mindfulness-based phsycial exercise intervention

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.

Intervention Type: OTHER

health education

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Community-dwelling people aged 60 years or older

2. Diagnosed with sarcopenia by the criteria of the Asian Working Group for Sarcopenia (AWGS):

1. decreased muscle strength: handgrip strength of males < 28 kg; handgrip strength of females < 18 kg;

2. or decreased physical performance: the time of 5-time chair stand test ≥12 s;

3. or decreased muscle mass: SMI of males is < 7.0 kg/m2; SMI of females is < 5.7 kg/m2

3. Able to communicate and written and understand the instruction

Exclusion Criteria

1. Been hospitalized for more than 5 days in the preceding 3 months

2. Unable to have body composition test, such as having heart pacemaker, vascular stent, steel plates and nails in the body

3. Contraindications to exercise, such as severe musculoskeletal disorders, severe cardiovascular diseases or spinal nerve injury

4. 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

5. Practicing mindfulness/yoga for >45 min a week in the 6 months prior to recruitment

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Patrick KOR Pui Kin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hong Kong Polytechnic University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Patrick KOR, PhD

Role: CONTACT

patrick.kor@polyu.edu.hk

(852) 27665622

Facility Contacts

Mengli LI, PhD

Role: primary

mengli.li@connect.polyu.hk

(86) 18351075005

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Other Identifiers

Mindful PE Sarcope

Identifier Type: -

Identifier Source: org_study_id