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

NCT05982067 | Unknown

• 1 other identifier: Mindful PE Sarcope
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (9)

• Skeletal muscle mass index

  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 the short form Geriatric Depression Scale (GDS-15)

  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)

• The Chinese Version of the Physical Activity Scale for the Elderly (PASE-C)

  baseline (T0) and week 12 (T1, immediately post-intervention)

Study Arms (2)

mindfulness-based physical exercie

EXPERIMENTAL

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

Health education

PLACEBO COMPARATOR

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

Other: health education

Interventions

mindfulness-based phsycial exercise intervention 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.

mindfulness-based physical exercie

health education 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.

Health education

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Suzhou, Jiangsu, 215000, China

RECRUITING

Related Publications (20)

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• Li ML, Kor PP, Zhang ZY, Liu JY. Feasibility and preliminary effects of a mindfulness-based physical exercise (MBPE) program for community-dwelling older people with sarcopenia: A protocol for a parallel, two-armed pilot randomised controlled trial. PLoS One. 2024 Apr 18;19(4):e0302235. doi: 10.1371/journal.pone.0302235. eCollection 2024.

  PMID: 38635544 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Patrick KOR, PhD

CONTACT

(852) 27665622; patrick.kor@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 8, 2023
• Study Start: July 25, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-07

Locations

CN (1)