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

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06149871
• Other study ID #: MOHThailand
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2023
• Source: Ministry of Health, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: August 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Frailty
• Sarcopenia

Intervention

Behavioral:
• Physical activity
resistance, aerobic, and flexibility exercises

Locations

Country	Name	City	State
Thailand	Regional Health Promotion Center 2 Phitsanulok	Phitsanulok

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Thailand	Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Physical frailty status based on the 5 criteria of frailty phenotype, as defined by Fried et al. 2001.	Frailty phenotype assessment followed Fried et al.'s (2001) criteria, including weakness, slowness, unintentional weight loss, exhaustion, and low physical activity. Participants were categorized as "frail" if they met three or more criteria, "pre-frail" with one or two, and "robust" if none were fulfilled.; (i) Weakness: Handgrip strength measured with a dynamometer. (ii) Slowness: Assessed by the time taken in a 15-feet walk test. (iii) Unintentional Weight Loss: Evaluated by recording weight loss exceeding 10 pounds or 5% in the last 3 months.; (iv) Exhaustion: Assessed with two questions from the CES-D depression scale. (v) Low Physical Activity: Determined by asking about the frequency of moderate physical activities in the past week.; Participants underwent assessments at both the beginning and the 30-week endpoint.	30 weeks