SarcopeniaNCT06149871
Effectiveness of Individual Physical Activity Programs to Prevent Sarcopenia and Frailty Among Older Adults
A study testing Physical activity in people with Sarcopenia and Frailty, run by Ministry of Health, Thailand at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Frailty
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged between 60 and 80 years.
- Those who are able to walk independently or with the aid of walking devices.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Regional Health Promotion Center 2 Phitsanulok
Phitsanulok, 65000
About this study
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
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.
Read the 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.
- Conditions
- Sarcopenia, Frailty
- Being tested
- Physical activity
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
resistance, aerobic, and flexibility exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 weeks
Secondary outcomes (1)
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.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Mar 2021
- Primary completion28 Feb 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Thailand
- Sponsor type
- Other government
- Collaborators
- Chulalongkorn University
- Responsible party
- Principal investigator, Visaratana Therakomen, Ministry of Health, Thailand
- Investigators
- Visaratana Therakomen, Diploma, Principal investigator, Department of Health, Ministry of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149871
- Sponsor's protocol ID
- MOHThailand
- Status last verified
- Nov 2023
- First submitted
- 26 Sep 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes: There is a plan to make IPD and related data dictionaries available : all IPD that underlie results in a publication
Publications
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.
PubMed 24030238Cruz-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.
PubMed 20392703Dent 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.
PubMed 30498820Dent 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.
PubMed 31641726Fried 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.
PubMed 11253156Afilalo 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.
PubMed 27568870
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06149871
- Acronym / sponsor ID
- MOHThailand
- Conditions
- Sarcopenia, Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Ministry of Health, ThailandOther government
- Collaborators
- Chulalongkorn University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Physical activityThe 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. |
| Control | No intervention | –The control group did not receive any intervention apart from general suggestions and continued with their usual daily activities. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals aged between 60 and 80 years.
- Those who are able to walk independently or with the aid of walking devices.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityresistance, aerobic, and flexibility exercises | Behavioural | Intervention |
Primary outcome
The status of sarcopenia aligns with the criteria set by the Asian Working Group for Sarcopenia (AWGS).
Time frame: 30 weeks
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.
Muscle strength
Time frame: 30 weeks
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.
Physical performance
Time frame: 30 weeks
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.
Muscle mass
Time frame: 30 weeks
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.
1 secondary outcome
Physical frailty status based on the 5 criteria of frailty phenotype, as defined by Fried et al. 2001.
Time frame: 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 24030238Cadore 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.
- Background: PubMed 20392703Cruz-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.
- Background: PubMed 30498820Dent 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.
- Background: PubMed 31641726Dent 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.
- Background: PubMed 11253156Fried 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.
- Results publication: PubMed 27568870Afilalo 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.
- Individual participant dataSharing planned: Yes. Yes: There is a plan to make IPD and related data dictionaries available : all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Visaratana Therakomen, Diploma principal investigator
Department of Health, Ministry of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Sarcopenia and Frailty, run by Ministry of Health, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The status of sarcopenia aligns with the criteria set by the Asian Working Group for Sarcopenia (AWGS). (time frame: 30 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06149871, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.