SarcopeniaNCT06094413
Effects of Multicomponent Training in Older Adults
A study testing Multicomponent Training Intervention in people with Sarcopenia, run by Geisinger Clinic at 1 site in United States.
Trial summary
The purpose of the study was to determine whether community-dwelling older adults would experience improved patient-reported outcomes and physical performance after completing an 8-week multicomponent exercise training program when compared to a control group who did not complete the intervention. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Multicomponent Training Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to 17 Dec 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age greater than or equal to 65 years
- able and willing to provide consent
- patient of Geisinger 65Forward Scranton clinic
Who cannot join
- Diagnosis of mild cognitive impairment, neurological disorders, uncontrolled metabolic disease, history of pacemaker or cardiovascular disease or high blood pressure not controlled with medication
- Previous history of musculoskeletal surgery or injury that could affect mobility
- An inability to perform an exercise program independently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of an 8-week Multicomponent Training Program on Quality of Life, Fear of Falling, &Amp; Physical Performance in Community-Dwelling Older Adults
The purpose of the study was to determine whether community-dwelling older adults would experience improved patient-reported outcomes and physical performance after completing an 8-week multicomponent exercise training program when compared to a control group who did not complete the intervention. As an additional aim, subjects who participated in the exercise intervention were asked about their experiences to identify factors that contributed to positive health behaviors in community-dwelling older adults.
Read the detailed description
Sarcopenia is a geriatric syndrome which involves the progressive loss of muscle mass and physical performance in aging adults. The age-related decline inherent to sarcopenia has been associated with an increased risk of falls, disability, and mortality. Exercise is a non-pharmacological intervention that has been shown to prevent and manage age-related loss of muscle mass and strength, however there is limited research regarding its effect on patient-reported outcomes in older adults.
The purpose of this study is to examine the effects of an 8-week multicomponent training program on quality of life, fear of falling, and physical performance in community-dwelling older adults. A convenient sample of community-dwelling older adults aged 65 years and older from an outpatient medical center in Northeast Pennsylvania were recruited to participate. Eligible subjects volunteered to participate in the intervention, which consisted of two group-based sixty-minute standardized sessions per week supervised by an experienced professional in the outpatient medical center, or a control group composed of patients who did not perform the intervention. Outcomes testing was performed for both groups prior to, at the mid-point (4 weeks), and following the completion of the exercise intervention (8 weeks). Semi-structured, individual interviews with selected participants who completed the intervention were conducted by the researcher in the designated research environment to assess barriers, drivers, and the overall experience of the intervention.
The study evaluated the following research questions:
- Will an 8-week multicomponent exercise intervention improve quality of life in community-dwelling older adults with probable sarcopenia?
- Will an 8-week multicomponent exercise intervention improve fear of falling in community-dwelling older adults with probable sarcopenia?
- Will an 8-week multicomponent exercise intervention improve physical performance in community-dwelling older adults with probable sarcopenia?
- Will an 8-week multicomponent exercise intervention improve hand grip strength in community-dwelling older adults with probable sarcopenia?
- What are the drivers and barriers of exercise adherence for community-dwelling older adults with probable sarcopenia who experienced an 8-week multicomponent exercise intervention?
A two-way ANOVA (group x time) was utilized for data analysis to determine between-group effects. Tukey post hoc testing was used to evaluate where differences occurred (pre-, mid-, post-). General ideas and emerging themes were inductively coded by the researcher and an independent content specialist utilizing the data from post-intervention interview transcripts.
The study was significant because it assessed whether the program was a feasible intervention that could be implemented by providers to aid in the management of age-related loss of muscle strength and physical performance for community-dwelling older adults. The findings of this study offered providers evidence-based practices that could be used for effective multicomponent exercise training prescription.
- Conditions
- Sarcopenia
- Being tested
- Multicomponent Training Intervention
- Keywords
- Multicomponent Physical Activity, Older Adult, Quality of Life, Fear of Falling, Physical Performance
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Training InterventionBehavioural
The intervention was implemented and supervised by a well-trained, highly experienced professional with post-graduate education in the fields of exercise science and health promotion. Each session consisted of three phases: warm-up/initiation, conditioning, and cooldown. The intervention was composed of aerobic, resistance, balance, and flexibility exercises. At each session subjects werre informed of the program goals and the methods used to document exercise tolerance of the session's training loads. The quality of the intervention was measured by patient compliance, adherence, and feedback such as rates of perceived exertion (RPE) which were monitored during the session to measure immediate effect of the intervention. Progressions were guided by individual responsiveness and measured by RPE. Progressions were based on the training principles of specificity, adaptability, and overload.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Training Intervention | Experimental | Subjects in the intervention group attended two standardized group-based sixty-minute sessions per week in the outpatient medical center and were asked not to change their current physical activity regimen during the 8-week duration of the study. Receives: Behavioral: Multicomponent Training Intervention |
| Control Group | No intervention | Subjects in the control group were asked to not change their current level of physical activity during the 8-week duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB) composite score
The SPPB was utilized to measure physical performance in the present study. The SPPB is a valid and reliable tool for assessing lower extremity function and mobility in community-dwelling adults. The SPPB score measures lower extremity functional performance among older adults by assessing chair stand time, gait speed, and standing balance. SPPB scores range from zero (worst performance) to twelve (best performance) possible points.
Measured: Prior to the start of the intervention (Week 1), Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
Falls Efficacy Scale (FES) score
The FES is a tool that was developed to assess self-confidence while performing physical activity in conjunction with a fear of falling.The questionnaire addressed a patient's confidence in carrying out 10 daily tasks without falling. The FES score ranged from 10 (highest level of confidence) to 100 (lowest level of confidence) points. A score of greater than 80 indicates an increased risk of falling. A score of greater than 70 indicates a fear of falling.
Measured: Prior to the start of the intervention (Week 1), Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
Sarcopenia Quality of Life (SarQoL) score
The SarQoL is a patient-reported outcome measurement (PROM) designed to assess quality of life in individuals aged 65 years and older who have been diagnosed with sarcopenia. It is a self-administered questionnaire including 22 questions, rated on a 4-point Likert scale. It assessed perceived domains such as physical and mental health, fears, and functionality in daily life. Each domain was scored from 0-100 and an Overall Score was calculated. The total scoring ranged from 0(worst imaginable health) to 100 (best imaginable health).
Measured: Prior to the start of the intervention (Week 1), Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
Secondary outcomes (1)
Hand Grip Strength score
A hand dynamometer was used to assess hand grip strength in both upper extremities. The instrument score was calculated in kg (0-90) with a lower score indicating lower hand grip strength and a higher score indicating higher hand grip strength.
Measured: Pre-intervention during the screening process, Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start4 Mar 2024
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A mixed-methods study design was used to assess the effectiveness of a multicomponent training program on quality of life, fear of falling, and physical performance in older adults. The study included a pre-mid-post-test design with an intervention group who performed an 8-week multicomponent training program and a control group composed of patients who do not perform the intervention.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenda Goodrich, DO, Principal investigator, Geisinger ClinicShala Davis, PhD, Study chair, East Stroudsburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094413
- Sponsor's protocol ID
- 2023-1091
- Status last verified
- Feb 2025
- First submitted
- 16 Oct 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
PubMed 2229948American Psychological Association. (2023). Mild cognitive impairment. In APA dictionary of psychology. https://dictionary.apa.org/mild-cognitive-impairment
Beaudart C, Biver E, Reginster JY, Rizzoli R, Rolland Y, Bautmans I, Petermans J, Gillain S, Buckinx F, Dardenne N, Bruyere O. Validation of the SarQoL(R), a specific health-related quality of life questionnaire for Sarcopenia. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):238-244. doi: 10.1002/jcsm.12149. Epub 2016 Oct 22.
PubMed 27897430Bohannon RW. Minimal clinically important difference for grip strength: a systematic review. J Phys Ther Sci. 2019 Jan;31(1):75-78. doi: 10.1589/jpts.31.75. Epub 2019 Jan 10.
PubMed 30774209Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
PubMed 32033882Cruz-Jentoft, A.J., Bahat, G., Bauer, J., Boirie, Y., Bruyere, O., Cederholm, T., Cooper, C., Landi, F., Rolland, Y., Sayer, A.A., Schneider, S.M., Sieber, C.C., Topinkova, E., Vandwoude, M., Visser, M., Zamboni, M.,.the Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), & the Extended Group for EWGSOP2. (2019). Sarcopenia: revised European consensus on definition and diagnosis. Age and Ageing, 48,16-31. https://doi.org/10.1093/ageing/afy169
de Fatima Ribeiro Silva C, Ohara DG, Matos AP, Pinto ACPN, Pegorari MS. Short Physical Performance Battery as a Measure of Physical Performance and Mortality Predictor in Older Adults: A Comprehensive Literature Review. Int J Environ Res Public Health. 2021 Oct 10;18(20):10612. doi: 10.3390/ijerph182010612.
PubMed 34682359Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.
PubMed 20061508de Mello RGB, Dalla Corte RR, Gioscia J, Moriguchi EH. Effects of Physical Exercise Programs on Sarcopenia Management, Dynapenia, and Physical Performance in the Elderly: A Systematic Review of Randomized Clinical Trials. J Aging Res. 2019 Nov 20;2019:1959486. doi: 10.1155/2019/1959486. eCollection 2019.
PubMed 31827927Dismore L, Hurst C, Sayer AA, Stevenson E, Aspray T, Granic A. Study of the Older Adults' Motivators and Barriers Engaging in a Nutrition and Resistance Exercise Intervention for Sarcopenia: An Embedded Qualitative Project in the MIlkMAN Pilot Study. Gerontol Geriatr Med. 2020 May 19;6:2333721420920398. doi: 10.1177/2333721420920398. eCollection 2020 Jan-Dec.
PubMed 32490038Fielding RA, Rejeski WJ, Blair S, Church T, Espeland MA, Gill TM, Guralnik JM, Hsu FC, Katula J, King AC, Kritchevsky SB, McDermott MM, Miller ME, Nayfield S, Newman AB, Williamson JD, Bonds D, Romashkan S, Hadley E, Pahor M; LIFE Research Group. The Lifestyle Interventions and Independence for Elders Study: design and methods. J Gerontol A Biol Sci Med Sci. 2011 Nov;66(11):1226-37. doi: 10.1093/gerona/glr123. Epub 2011 Aug 8.
PubMed 21825283Geerinck A, Alekna V, Beaudart C, Bautmans I, Cooper C, De Souza Orlandi F, Konstantynowicz J, Montero-Errasquin B, Topinkova E, Tsekoura M, Reginster JY, Bruyere O. Standard error of measurement and smallest detectable change of the Sarcopenia Quality of Life (SarQoL) questionnaire: An analysis of subjects from 9 validation studies. PLoS One. 2019 Apr 29;14(4):e0216065. doi: 10.1371/journal.pone.0216065. eCollection 2019.
PubMed 31034498Geriatrics. American Physical Therapy Association (APTA). (2021). Outcome measure toolkit for geriatric fall/balance assessment. https://www.aptageriatrics.org/special-interest-groups/balance-falls/Outcome-Measure-Toolkit/Outcome%20Measures%20Toolkit%202020.pdf
Hecksteden A, Faude O, Meyer T, Donath L. How to Construct, Conduct and Analyze an Exercise Training Study? Front Physiol. 2018 Jul 26;9:1007. doi: 10.3389/fphys.2018.01007. eCollection 2018.
PubMed 30140237Jenkins NDM, Cramer JT. Reliability and Minimum Detectable Change for Common Clinical Physical Function Tests in Sarcopenic Men and Women. J Am Geriatr Soc. 2017 Apr;65(4):839-846. doi: 10.1111/jgs.14769. Epub 2017 Mar 15.
PubMed 28295148
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an 8-week Multicomponent Training Program on Quality of Life, Fear of Falling, &Amp; Physical Performance in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT06094413
- Acronym / sponsor ID
- 2023-1091
- Conditions
- Sarcopenia
- Keywords
- Multicomponent Physical Activity, Older Adult, Quality of Life, Fear of Falling, Physical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 23 Oct 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.
The purpose of the study was to determine whether community-dwelling older adults would experience improved patient-reported outcomes and physical performance after completing an 8-week multicomponent exercise training program when compared to a control group who did not complete the intervention. As an additional aim, subjects who participated in the exercise intervention were asked about their experiences to identify factors that contributed to positive health behaviors in community-dwelling older adults.
Detailed description
Sarcopenia is a geriatric syndrome which involves the progressive loss of muscle mass and physical performance in aging adults. The age-related decline inherent to sarcopenia has been associated with an increased risk of falls, disability, and mortality. Exercise is a non-pharmacological intervention that has been shown to prevent and manage age-related loss of muscle mass and strength, however there is limited research regarding its effect on patient-reported outcomes in older adults.
The purpose of this study is to examine the effects of an 8-week multicomponent training program on quality of life, fear of falling, and physical performance in community-dwelling older adults. A convenient sample of community-dwelling older adults aged 65 years and older from an outpatient medical center in Northeast Pennsylvania were recruited to participate. Eligible subjects volunteered to participate in the intervention, which consisted of two group-based sixty-minute standardized sessions per week supervised by an experienced professional in the outpatient medical center, or a control group composed of patients who did not perform the intervention. Outcomes testing was performed for both groups prior to, at the mid-point (4 weeks), and following the completion of the exercise intervention (8 weeks). Semi-structured, individual interviews with selected participants who completed the intervention were conducted by the researcher in the designated research environment to assess barriers, drivers, and the overall experience of the intervention.
The study evaluated the following research questions:
- Will an 8-week multicomponent exercise intervention improve quality of life in community-dwelling older adults with probable sarcopenia?
- Will an 8-week multicomponent exercise intervention improve fear of falling in community-dwelling older adults with probable sarcopenia?
- Will an 8-week multicomponent exercise intervention improve physical performance in community-dwelling older adults with probable sarcopenia?
- Will an 8-week multicomponent exercise intervention improve hand grip strength in community-dwelling older adults with probable sarcopenia?
- What are the drivers and barriers of exercise adherence for community-dwelling older adults with probable sarcopenia who experienced an 8-week multicomponent exercise intervention?
A two-way ANOVA (group x time) was utilized for data analysis to determine between-group effects. Tukey post hoc testing was used to evaluate where differences occurred (pre-, mid-, post-). General ideas and emerging themes were inductively coded by the researcher and an independent content specialist utilizing the data from post-intervention interview transcripts.
The study was significant because it assessed whether the program was a feasible intervention that could be implemented by providers to aid in the management of age-related loss of muscle strength and physical performance for community-dwelling older adults. The findings of this study offered providers evidence-based practices that could be used for effective multicomponent exercise training prescription.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A mixed-methods study design was used to assess the effectiveness of a multicomponent training program on quality of life, fear of falling, and physical performance in older adults. The study included a pre-mid-post-test design with an intervention group who performed an 8-week multicomponent training program and a control group composed of patients who do not perform the intervention.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Training Intervention | Experimental | Behavioral: Multicomponent Training InterventionSubjects in the intervention group attended two standardized group-based sixty-minute sessions per week in the outpatient medical center and were asked not to change their current physical activity regimen during the 8-week duration of the study. |
| Control Group | No intervention | –Subjects in the control group were asked to not change their current level of physical activity during the 8-week duration of the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age greater than or equal to 65 years
- able and willing to provide consent
- patient of Geisinger 65Forward Scranton clinic
Key exclusion criteria (3 listed)
- Diagnosis of mild cognitive impairment, neurological disorders, uncontrolled metabolic disease, history of pacemaker or cardiovascular disease or high blood pressure not controlled with medication
- Previous history of musculoskeletal surgery or injury that could affect mobility
- An inability to perform an exercise program independently
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 |
|---|---|---|
| Multicomponent Training InterventionThe intervention was implemented and supervised by a well-trained, highly experienced professional with post-graduate education in the fields of exercise science and health promotion. Each session consisted of three phases: warm-up/initiation, conditioning, and cooldown. The intervention was composed of aerobic, resistance, balance, and flexibility exercises. At each session subjects werre informed of the program goals and the methods used to document exercise tolerance of the session's training loads. The quality of the intervention was measured by patient compliance, adherence, and feedback such as rates of perceived exertion (RPE) which were monitored during the session to measure immediate effect of the intervention. Progressions were guided by individual responsiveness and measured by RPE. Progressions were based on the training principles of specificity, adaptability, and overload. | Behavioural | Multicomponent Training Intervention |
Primary outcome
Short Physical Performance Battery (SPPB) composite score
Time frame: Prior to the start of the intervention (Week 1), Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
The SPPB was utilized to measure physical performance in the present study. The SPPB is a valid and reliable tool for assessing lower extremity function and mobility in community-dwelling adults. The SPPB score measures lower extremity functional performance among older adults by assessing chair stand time, gait speed, and standing balance. SPPB scores range from zero (worst performance) to twelve (best performance) possible points.
Falls Efficacy Scale (FES) score
Time frame: Prior to the start of the intervention (Week 1), Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
The FES is a tool that was developed to assess self-confidence while performing physical activity in conjunction with a fear of falling.The questionnaire addressed a patient's confidence in carrying out 10 daily tasks without falling. The FES score ranged from 10 (highest level of confidence) to 100 (lowest level of confidence) points. A score of greater than 80 indicates an increased risk of falling. A score of greater than 70 indicates a fear of falling.
Sarcopenia Quality of Life (SarQoL) score
Time frame: Prior to the start of the intervention (Week 1), Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
The SarQoL is a patient-reported outcome measurement (PROM) designed to assess quality of life in individuals aged 65 years and older who have been diagnosed with sarcopenia. It is a self-administered questionnaire including 22 questions, rated on a 4-point Likert scale. It assessed perceived domains such as physical and mental health, fears, and functionality in daily life. Each domain was scored from 0-100 and an Overall Score was calculated. The total scoring ranged from 0(worst imaginable health) to 100 (best imaginable health).
1 secondary outcome
Hand Grip Strength score
Time frame: Pre-intervention during the screening process, Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
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 5 Feb 2025.
- Background: PubMed 2229948Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
- BackgroundAmerican Psychological Association. (2023). Mild cognitive impairment. In APA dictionary of psychology. https://dictionary.apa.org/mild-cognitive-impairment
- Background: PubMed 27897430Beaudart C, Biver E, Reginster JY, Rizzoli R, Rolland Y, Bautmans I, Petermans J, Gillain S, Buckinx F, Dardenne N, Bruyere O. Validation of the SarQoL(R), a specific health-related quality of life questionnaire for Sarcopenia. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):238-244. doi: 10.1002/jcsm.12149. Epub 2016 Oct 22.
- Background: PubMed 30774209Bohannon RW. Minimal clinically important difference for grip strength: a systematic review. J Phys Ther Sci. 2019 Jan;31(1):75-78. doi: 10.1589/jpts.31.75. Epub 2019 Jan 10.
- Background: PubMed 32033882Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
- BackgroundCruz-Jentoft, A.J., Bahat, G., Bauer, J., Boirie, Y., Bruyere, O., Cederholm, T., Cooper, C., Landi, F., Rolland, Y., Sayer, A.A., Schneider, S.M., Sieber, C.C., Topinkova, E., Vandwoude, M., Visser, M., Zamboni, M.,.the Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), & the Extended Group for EWGSOP2. (2019). Sarcopenia: revised European consensus on definition and diagnosis. Age and Ageing, 48,16-31. https://doi.org/10.1093/ageing/afy169
- Background: PubMed 34682359de Fatima Ribeiro Silva C, Ohara DG, Matos AP, Pinto ACPN, Pegorari MS. Short Physical Performance Battery as a Measure of Physical Performance and Mortality Predictor in Older Adults: A Comprehensive Literature Review. Int J Environ Res Public Health. 2021 Oct 10;18(20):10612. doi: 10.3390/ijerph182010612.
- Background: PubMed 20061508Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.
- Background: PubMed 31827927de Mello RGB, Dalla Corte RR, Gioscia J, Moriguchi EH. Effects of Physical Exercise Programs on Sarcopenia Management, Dynapenia, and Physical Performance in the Elderly: A Systematic Review of Randomized Clinical Trials. J Aging Res. 2019 Nov 20;2019:1959486. doi: 10.1155/2019/1959486. eCollection 2019.
- Background: PubMed 32490038Dismore L, Hurst C, Sayer AA, Stevenson E, Aspray T, Granic A. Study of the Older Adults' Motivators and Barriers Engaging in a Nutrition and Resistance Exercise Intervention for Sarcopenia: An Embedded Qualitative Project in the MIlkMAN Pilot Study. Gerontol Geriatr Med. 2020 May 19;6:2333721420920398. doi: 10.1177/2333721420920398. eCollection 2020 Jan-Dec.
- Background: PubMed 21825283Fielding RA, Rejeski WJ, Blair S, Church T, Espeland MA, Gill TM, Guralnik JM, Hsu FC, Katula J, King AC, Kritchevsky SB, McDermott MM, Miller ME, Nayfield S, Newman AB, Williamson JD, Bonds D, Romashkan S, Hadley E, Pahor M; LIFE Research Group. The Lifestyle Interventions and Independence for Elders Study: design and methods. J Gerontol A Biol Sci Med Sci. 2011 Nov;66(11):1226-37. doi: 10.1093/gerona/glr123. Epub 2011 Aug 8.
- Background: PubMed 31034498Geerinck A, Alekna V, Beaudart C, Bautmans I, Cooper C, De Souza Orlandi F, Konstantynowicz J, Montero-Errasquin B, Topinkova E, Tsekoura M, Reginster JY, Bruyere O. Standard error of measurement and smallest detectable change of the Sarcopenia Quality of Life (SarQoL) questionnaire: An analysis of subjects from 9 validation studies. PLoS One. 2019 Apr 29;14(4):e0216065. doi: 10.1371/journal.pone.0216065. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Brenda Goodrich, DO principal investigator
Geisinger Clinic
Shala Davis, PhD study chair
East Stroudsburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Training Intervention in people with Sarcopenia, run by Geisinger Clinic at 1 site in United States.
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 3 inclusion and 3 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 5 Feb 2025. 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 United States. 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?
Short Physical Performance Battery (SPPB) composite score (time frame: Prior to the start of the intervention (Week 1), Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)). The study lists 3 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 NCT06094413, which also lists 28 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 5 Feb 2025.