Clinical trial NCT05982067: MIndfulness-based Physical Exercise Program (MIPE Program) on Sarcopenia
Official title: The Utility of MIndfulness-based Physical Exercise Program (MIPE Program) for Community-dwelling Older People With Sarcopenia: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time spent recruiting participants
timeFrame: baseline (T0)
measure: Eligibility rate
timeFrame: baseline (T0)
measure: Recruitment rate
timeFrame: baseline (T0)
measure: Attendance rate
timeFrame: week 12 (T1)
measure: Complete rate
timeFrame: week 12 (T1)
measure: Attrition rate
timeFrame: week 12 (T1)
measure: The participants' perspectives on the intervention
timeFrame: week 12 (T1)
Secondary outcomes:
measure: Skeletal muscle mass index
timeFrame: baseline (T0) and week 12 (T1, immediately post-intervention)
measure: The Chinese version of the Behavioral Regulation in Exercise Questionnaire-2 (C-BREQ-2)
timeFrame: baseline (T0) and week 12 (T1, immediately post-intervention)
measure: The Chinese version of the short form Geriatric Depression Scale (GDS-15)
timeFrame: baseline (T0) and week 12 (T1, immediately post-intervention)
measure: The Chinese version of Raff's Psychological Well-being Scale (RPWS-C)
timeFrame: baseline (T0) and week 12 (T1, immediately post-intervention)
measure: The Chinese Version of the Physical Activity Scale for the Elderly (PASE-C)
timeFrame: baseline (T0) and week 12 (T1, immediately post-intervention)
measure: The Chinese version of Five Facet Mindfulness Questionnaire (FFMQ-15-C)
timeFrame: baseline (T0) and week 12 (T1, immediately post-intervention)
measure: The Chinese version of Sarcopenia and Quality of life (SarQoL®)
timeFrame: baseline (T0) and week 12 (T1, immediately post-intervention)
measure: Handgrip strength
timeFrame: baseline (T0) and week 12 (T1, immediately post-intervention)
measure: 5-times Chair stand test
timeFrame: baseline (T0) and week 12 (T1, immediately post-intervention)
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The Hong Kong Polytechnic University
state: Jiangsu
Study officials:
References:
citation: Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.
citation: Mayhew AJ, Amog K, Phillips S, Parise G, McNicholas PD, de Souza RJ, Thabane L, Raina P. The prevalence of sarcopenia in community-dwelling older adults, an exploration of differences between studies and within definitions: a systematic review and meta-analyses. Age Ageing. 2019 Jan 1;48(1):48-56. doi: 10.1093/ageing/afy106.
citation: Cao L, Morley JE. Sarcopenia Is Recognized as an Independent Condition by an International Classification of Disease, Tenth Revision, Clinical Modification (ICD-10-CM) Code. J Am Med Dir Assoc. 2016 Aug 1;17(8):675-7. doi: 10.1016/j.jamda.2016.06.001. No abstract available.
citation: Beaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyere O. Health Outcomes of Sarcopenia: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 17;12(1):e0169548. doi: 10.1371/journal.pone.0169548. eCollection 2017.
citation: Peng TC, Chen WL, Wu LW, Chang YW, Kao TW. Sarcopenia and cognitive impairment: A systematic review and meta-analysis. Clin Nutr. 2020 Sep;39(9):2695-2701. doi: 10.1016/j.clnu.2019.12.014. Epub 2019 Dec 17.
citation: Chang KV, Hsu TH, Wu WT, Huang KC, Han DS. Is sarcopenia associated with depression? A systematic review and meta-analysis of observational studies. Age Ageing. 2017 Sep 1;46(5):738-746. doi: 10.1093/ageing/afx094.
citation: Cho HW, Chung W, Moon S, Ryu OH, Kim MK, Kang JG. Effect of Sarcopenia and Body Shape on Cardiovascular Disease According to Obesity Phenotypes. Diabetes Metab J. 2021 Mar;45(2):209-218. doi: 10.4093/dmj.2019.0223. Epub 2020 Jul 10.
citation: Yang M, Liu Y, Zuo Y, Tang H. Sarcopenia for predicting falls and hospitalization in community-dwelling older adults: EWGSOP versus EWGSOP2. Sci Rep. 2019 Nov 27;9(1):17636. doi: 10.1038/s41598-019-53522-6.
citation: Nakamura K, Yoshida D, Honda T, Hata J, Shibata M, Hirakawa Y, Furuta Y, Kishimoto H, Ohara T, Kitazono T, Nakashima Y, Ninomiya T. Prevalence and Mortality of Sarcopenia in a Community-dwelling Older Japanese Population: The Hisayama Study. J Epidemiol. 2021 May 5;31(5):320-327. doi: 10.2188/jea.JE20190289. Epub 2020 Oct 17.
citation: Su Y, Hirayama K, Han TF, Izutsu M, Yuki M. Sarcopenia Prevalence and Risk Factors among Japanese Community Dwelling Older Adults Living in a Snow-Covered City According to EWGSOP2. J Clin Med. 2019 Feb 28;8(3):291. doi: 10.3390/jcm8030291.
citation: Bruyere O, Beaudart C, Ethgen O, Reginster JY, Locquet M. The health economics burden of sarcopenia: a systematic review. Maturitas. 2019 Jan;119:61-69. doi: 10.1016/j.maturitas.2018.11.003. Epub 2018 Nov 12.
citation: Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
citation: Hurst C, Robinson SM, Witham MD, Dodds RM, Granic A, Buckland C, De Biase S, Finnegan S, Rochester L, Skelton DA, Sayer AA. Resistance exercise as a treatment for sarcopenia: prescription and delivery. Age Ageing. 2022 Feb 2;51(2):afac003. doi: 10.1093/ageing/afac003.
citation: Wu PY, Huang KS, Chen KM, Chou CP, Tu YK. Exercise, Nutrition, and Combined Exercise and Nutrition in Older Adults with Sarcopenia: A Systematic Review and Network Meta-analysis. Maturitas. 2021 Mar;145:38-48. doi: 10.1016/j.maturitas.2020.12.009. Epub 2020 Dec 31.
citation: Yoshimura Y, Wakabayashi H, Yamada M, Kim H, Harada A, Arai H. Interventions for Treating Sarcopenia: A Systematic Review and Meta-Analysis of Randomized Controlled Studies. J Am Med Dir Assoc. 2017 Jun 1;18(6):553.e1-553.e16. doi: 10.1016/j.jamda.2017.03.019.
citation: Li ML, Kor PP, Sui YF, Liu JY. Health maintenance through home-based interventions for community-dwelling older people with sarcopenia during and after the COVID-19 pandemic: A systematic review and meta-analysis. Exp Gerontol. 2023 Apr;174:112128. doi: 10.1016/j.exger.2023.112128. Epub 2023 Feb 21.
citation: Reangsing C, Rittiwong T, Schneider JK. Effects of mindfulness meditation interventions on depression in older adults: A meta-analysis. Aging Ment Health. 2021 Jul;25(7):1181-1190. doi: 10.1080/13607863.2020.1793901. Epub 2020 Jul 15.
citation: Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Wampold BE, Kearney DJ, Simpson TL. Mindfulness-based interventions for psychiatric disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2018 Feb;59:52-60. doi: 10.1016/j.cpr.2017.10.011. Epub 2017 Nov 8.
citation: Wang S, Yin H, Jia Y, Zhao L, Wang L, Chen L. Effects of Mind-Body Exercise on Cognitive Function in Older Adults With Cognitive Impairment: A Systematic Review and Meta-analysis. J Nerv Ment Dis. 2018 Dec;206(12):913-924. doi: 10.1097/NMD.0000000000000912.