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

NCT06149871 | Completed DMC

• 1 other identifier: MOHThailand
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Frailty

Outcome Measures

Primary Outcomes (4)

• The status of sarcopenia aligns with the criteria set by the Asian Working Group for Sarcopenia (AWGS).

  Sarcopenia status was assessed through three aspects, including a muscle strength test using handgrip strength measured with a dynamometer, a physical performance test using the Short Physical Performance Battery (SPPB), and an appendicular skeletal muscle mass (ASM) test measured with the ACCUNIQ BC 380 tool based on bioelectrical impedance analysis (BIA). The results were aligned with the standards set by the Asian Working Group for Sarcopenia (AWGS). Sarcopenia was diagnosed by low ASM with low muscle strength or low physical performance, dynapenia was diagnosed by low muscle strength only, and pre-sarcopenia was diagnosed by low ASM or low physical performance. Participants underwent assessments both at the beginning and at the 30-week endpoint.

  30 weeks

• Muscle strength

  Muscle strength, specifically handgrip strength, was measured using a hand-held dynamometer. Participants gripped the dynamometer with their dominant hand while standing, maintaining their upper arm close to the body and their elbow bent to 90 degrees, exerting maximum force. This test was conducted twice, and the superior result was recorded. Low muscle strength was diagnosed if the handgrip strength was \< 26 kilograms in males and \< 18 kilograms in females. Participants underwent assessments at both the beginning and the 30-week endpoint.

  30 weeks

• Physical performance

  The physical performance test utilized the Short Physical Performance Battery (SPPB) to evaluate physical function, with a maximum score of 12 points. Low physical performance was diagnosed if the SPPB score was ≤ 9. Participants underwent assessments at both the beginning and the 30-week endpoint.

  30 weeks

• Muscle mass

  Appendicular skeletal muscle mass (ASM) was measured using the ACCUNIQ BC 380 tool based on bioelectrical impedance analysis (BIA), and the Skeletal Muscle Mass Index (SMI) was calculated by dividing ASM in kilograms by the height in meters squared. Low muscle mass is diagnosed if SMI is \< 7.0 kilograms/meter\^2 in men and \< 5.47 kg/m\^2 in women. Participants underwent assessments at both the beginning and the 30-week endpoint.

  30 weeks

Secondary Outcomes (1)

• Physical frailty status based on the 5 criteria of frailty phenotype, as defined by Fried et al. 2001.

  30 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Physical activity

Control

NO INTERVENTION

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

Interventions

Physical activity BEHAVIORAL

resistance, aerobic, and flexibility exercises

Intervention

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ministry of Health, Thailand: lead
• Chulalongkorn University: collaborator

Study Sites (1)

Regional Health Promotion Center 2 Phitsanulok

Phitsanulok, 65000, Thailand

Location

Related Publications (6)

• 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.

  PMID: 24030238 BACKGROUND

• 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.

  PMID: 20392703 BACKGROUND

• 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.

  PMID: 30498820 BACKGROUND

• 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.

  PMID: 31641726 BACKGROUND

• 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.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 27568870 RESULT

MeSH Terms

Conditions

Sarcopenia; Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Visaratana Therakomen, Diploma

  Department of Health, Ministry of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director for Academic Affairs of Bureau of Nutrition, Department of Health

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: November 29, 2023
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: August 31, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: 1. Access Criteria: * Ethical Approval: Requestors must provide evidence of ethical approval from their respective institutions or review boards for the proposed analyses. * Data Security Measures: Researchers must demonstrate the implementation of robust data security measures to protect the confidentiality and integrity of the shared data. 2. Additional Supporting Information: * Study Protocol: A detailed study protocol outlining the objectives, methodologies, and analysis plan must be submitted along with the request for IPD access. * Data Dictionary: A comprehensive data dictionary defining variables, codes, and any transformations applied to the data should accompany the request.

Locations

TH (1)