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Effectiveness of Individual Physical Activity Programs to Prevent Sarcopenia and Frailty Among Older Adults

NCT ID: NCT06149871

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Sarcopenia Frailty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intervention

The Experimental groups or physical activity groups were assigned to three groups based on their muscle mass: normal, probable sarcopenia, and sarcopenia groups. The volunteers were provided with instructions on individual physical activities to be practiced at home for 30 weeks, 2-5 days per week and 50 minutes per session. These physical activities consisted of flexibility exercise for 10 minutes, aerobic exercise for 20 minutes, and resistance exercise for 20 minutes, as outlined in supplement 1. The volunteers were instructed on exercise techniques and physical activities by either sports scientists or registered nurses, and caregivers such as relatives or staff from the social club for older adults were allowed to be present during practice.

Group Type EXPERIMENTAL

Physical activity

Intervention Type BEHAVIORAL

resistance, aerobic, and flexibility exercises

Control

The control group did not receive any intervention apart from general suggestions and continued with their usual daily activities.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical activity

resistance, aerobic, and flexibility exercises

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role collaborator

Ministry of Health, Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Visaratana Therakomen

Deputy Director for Academic Affairs of Bureau of Nutrition, Department of Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Visaratana Therakomen, Diploma

Role: PRINCIPAL_INVESTIGATOR

Department of Health, Ministry of Public Health

Locations

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Regional Health Promotion Center 2 Phitsanulok

Phitsanulok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 24030238 (View on PubMed)

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

Reference Type BACKGROUND
PMID: 20392703 (View on PubMed)

Dent E, Morley JE, Cruz-Jentoft AJ, Arai H, Kritchevsky SB, Guralnik J, Bauer JM, Pahor M, Clark BC, Cesari M, Ruiz J, Sieber CC, Aubertin-Leheudre M, Waters DL, Visvanathan R, Landi F, Villareal DT, Fielding R, Won CW, Theou O, Martin FC, Dong B, Woo J, Flicker L, Ferrucci L, Merchant RA, Cao L, Cederholm T, Ribeiro SML, Rodriguez-Manas L, Anker SD, Lundy J, Gutierrez Robledo LM, Bautmans I, Aprahamian I, Schols JMGA, Izquierdo M, Vellas B. International Clinical Practice Guidelines for Sarcopenia (ICFSR): Screening, Diagnosis and Management. J Nutr Health Aging. 2018;22(10):1148-1161. doi: 10.1007/s12603-018-1139-9.

Reference Type BACKGROUND
PMID: 30498820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31641726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11253156 (View on PubMed)

Afilalo J. Conceptual Models of Frailty: The Sarcopenia Phenotype. Can J Cardiol. 2016 Sep;32(9):1051-5. doi: 10.1016/j.cjca.2016.05.017. Epub 2016 Jun 2.

Reference Type RESULT
PMID: 27568870 (View on PubMed)

Other Identifiers

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MOHThailand

Identifier Type: -

Identifier Source: org_study_id