Clinical trial NCT06149871: Effectiveness of Individual Physical Activity Programs to Prevent Sarcopenia and Frailty Among Older Adults
Official title: Effectiveness of Individual Physical Activity Programs to Prevent and Slow Progression of Sarcopenia and Frailty Among Thai Community-dwelling Older Adults: A Double-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Frailty
Lead sponsor: Ministry of Health, Thailand
Sponsor class: OTHER_GOV
Collaborators: name: Chulalongkorn University
First posted: 2023-11-29
Enrollment: 360
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sarcopenia and frailty could be prevented and rehabilitated through individual physical activities in the form of combined exercise that could be practiced at home in daily life.

Detailed description: The volunteers were randomly assigned to either the intervention or control group using sealed envelopes containing documents marked with either IG (intervention group) or CG (control group). The intervention group received training, after which they demonstrated and practiced the physical activities. They were provided with an exercise leaflet for self-practice at home and were followed up by phone, LINE application, and leaders of social club for older adults at least once a week to ensure regular practice. The older adults' relatives and caregivers were also trained and encouraged to practice with them in a 1:1 match. Support techniques and warning signs for stopping or taking a break during exercise were added to each posture, along with suggestions for suitable environmental management, such as flat plains, sufficient light, and no barriers within 2 meters, to reduce the risks of accidents. However, the control group did not receive any intervention apart from general suggestions and continued with their usual daily activities.

Eligibility criteria: Inclusion Criteria:

* Individuals aged between 60 and 80 years.
* Those who are able to walk independently or with the aid of walking devices.

Exclusion Criteria:

* Participants with leg or foot amputations.
* Participants who had been admitted to hospitals in the past 6 months.
* Those with underlying medical conditions such as heart disease, bone and muscle injuries, and infectious diseases.
* Individuals who did not pass the Physical Activity Readiness Questionnaire (PAR-Q).

Primary outcomes:
measure: The status of sarcopenia aligns with the criteria set by the Asian Working Group for Sarcopenia (AWGS).
timeFrame: 30 weeks
measure: Muscle strength
timeFrame: 30 weeks
measure: Physical performance
timeFrame: 30 weeks
measure: Muscle mass
timeFrame: 30 weeks
Secondary outcomes:
measure: Physical frailty status based on the 5 criteria of frailty phenotype, as defined by Fried et al. 2001.
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Phitsanulok
country: Thailand
facility: Regional Health Promotion Center 2 Phitsanulok
Study officials:
affiliation: Department of Health, Ministry of Public Health
name: Visaratana Therakomen, Diploma
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cadore EL, Casas-Herrero A, Zambom-Ferraresi F, Idoate F, Millor N, Gomez M, Rodriguez-Manas L, Izquierdo M. Multicomponent exercises including muscle power training enhance muscle mass, power output, and functional outcomes in institutionalized frail nonagenarians. Age (Dordr). 2014 Apr;36(2):773-85. doi: 10.1007/s11357-013-9586-z. Epub 2013 Sep 13.
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citation: Dent E, Morley JE, Cruz-Jentoft AJ, Woodhouse L, Rodriguez-Manas L, Fried LP, Woo J, Aprahamian I, Sanford A, Lundy J, Landi F, Beilby J, Martin FC, Bauer JM, Ferrucci L, Merchant RA, Dong B, Arai H, Hoogendijk EO, Won CW, Abbatecola A, Cederholm T, Strandberg T, Gutierrez Robledo LM, Flicker L, Bhasin S, Aubertin-Leheudre M, Bischoff-Ferrari HA, Guralnik JM, Muscedere J, Pahor M, Ruiz J, Negm AM, Reginster JY, Waters DL, Vellas B. Physical Frailty: ICFSR International Clinical Practice Guidelines for Identification and Management. J Nutr Health Aging. 2019;23(9):771-787. doi: 10.1007/s12603-019-1273-z.
citation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
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