Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2024-03-04
2024-12-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exercise for Adults With Limited Mobility
NCT05266573
Effectiveness of 8 Week Multicomponent Exercise Program in Older Adults With Frailty and Cognitive Impairment
NCT06440733
Impact of Brief Daily Functional Resistance Training on Lower Extremity Physical Performance
NCT06396247
Neuropsychological Effects of Strengthening Exercise for Older Adults
NCT00894205
Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly
NCT05317338
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. Will an 8-week multicomponent exercise intervention improve quality of life in community-dwelling older adults with probable sarcopenia?
2. Will an 8-week multicomponent exercise intervention improve fear of falling in community-dwelling older adults with probable sarcopenia?
3. Will an 8-week multicomponent exercise intervention improve physical performance in community-dwelling older adults with probable sarcopenia?
4. Will an 8-week multicomponent exercise intervention improve hand grip strength in community-dwelling older adults with probable sarcopenia?
5. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Multicomponent Training Intervention
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.
Multicomponent Training Intervention
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.
Control Group
Subjects in the control group were asked to not change their current level of physical activity during the 8-week duration of the study.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Multicomponent Training Intervention
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* able and willing to provide consent
* patient of Geisinger 65Forward Scranton clinic
Exclusion Criteria
* Previous history of musculoskeletal surgery or injury that could affect mobility
* An inability to perform an exercise program independently
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Geisinger Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brenda Goodrich, DO
Role: PRINCIPAL_INVESTIGATOR
Geisinger Clinic
Shala Davis, PhD
Role: STUDY_CHAIR
East Stroudsburg University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Geisinger 65Forward
Scranton, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
American 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.
Bohannon 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.
Chen 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.
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 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.
Delbaere 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.
de 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.
Dismore 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.
Fielding 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.
Geerinck 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.
Geriatrics. 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.
Jenkins 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.
Kaushal N, Langlois F, Desjardins-Crepeau L, Hagger MS, Bherer L. Investigating dose-response effects of multimodal exercise programs on health-related quality of life in older adults. Clin Interv Aging. 2019 Jan 24;14:209-217. doi: 10.2147/CIA.S187534. eCollection 2019.
Kumar P, Umakanth S, Girish N. A review of the components of exercise prescription for sarcopenic older adults. Eur Geriatr Med. 2022 Dec;13(6):1245-1280. doi: 10.1007/s41999-022-00693-7. Epub 2022 Sep 2.
Liguori, G. (2021). ACSM's Guidelines for Exercise Testing and Prescription, 11th Edition.
Makizako H, Nakai Y, Tomioka K, Taniguchi Y, Sato N, Wada A, Kiyama R, Tsutsumimoto K, Ohishi M, Kiuchi Y, Kubozono T, Takenaka T. Effects of a Multicomponent Exercise Program in Physical Function and Muscle Mass in Sarcopenic/Pre-Sarcopenic Adults. J Clin Med. 2020 May 8;9(5):1386. doi: 10.3390/jcm9051386.
Malmstrom TK, Miller DK, Simonsick EM, Ferrucci L, Morley JE. SARC-F: a symptom score to predict persons with sarcopenia at risk for poor functional outcomes. J Cachexia Sarcopenia Muscle. 2016 Mar;7(1):28-36. doi: 10.1002/jcsm.12048. Epub 2015 Jul 7.
Phu S, Kirk B, Bani Hassan E, Vogrin S, Zanker J, Bernardo S, Duque G. The diagnostic value of the Short Physical Performance Battery for sarcopenia. BMC Geriatr. 2020 Jul 13;20(1):242. doi: 10.1186/s12877-020-01642-4.
Rizzoli R, Reginster JY, Arnal JF, Bautmans I, Beaudart C, Bischoff-Ferrari H, Biver E, Boonen S, Brandi ML, Chines A, Cooper C, Epstein S, Fielding RA, Goodpaster B, Kanis JA, Kaufman JM, Laslop A, Malafarina V, Manas LR, Mitlak BH, Oreffo RO, Petermans J, Reid K, Rolland Y, Sayer AA, Tsouderos Y, Visser M, Bruyere O. Quality of life in sarcopenia and frailty. Calcif Tissue Int. 2013 Aug;93(2):101-20. doi: 10.1007/s00223-013-9758-y. Epub 2013 Jul 5.
Safonova, Y. A. (2020). Sarcopenia risk factor for falls and fractures. The Clinician, 13(3-4), 22-28. https://doi.org/10.17650/1818-8338-2019-13-3-4-22-28
Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement. Br J Sports Med. 2016 Dec;50(23):1428-1437. doi: 10.1136/bjsports-2016-096651. Epub 2016 Oct 5.
Tsekoura M, Billis E, Tsepis E, Dimitriadis Z, Matzaroglou C, Tyllianakis M, Panagiotopoulos E, Gliatis J. The Effects of Group and Home-Based Exercise Programs in Elderly with Sarcopenia: A Randomized Controlled Trial. J Clin Med. 2018 Nov 26;7(12):480. doi: 10.3390/jcm7120480.
U.S. Department of Health & Human Services. (2018). Physical Activity Guidelines for Americans, 2nd edition. https://health.gov/sites/default/files/2019-09/Physical_Activity_Guidelines_2nd_edition.pdf
Witham MD. Bridging the gap between the laboratory and the clinic for patients with sarcopenia. Biogerontology. 2019 Apr;20(2):241-248. doi: 10.1007/s10522-018-09793-z. Epub 2018 Dec 27.
Xia L, Zhao R, Wan Q, Wu Y, Zhou Y, Wang Y, Cui Y, Shen X, Wu X. Sarcopenia and adverse health-related outcomes: An umbrella review of meta-analyses of observational studies. Cancer Med. 2020 Nov;9(21):7964-7978. doi: 10.1002/cam4.3428. Epub 2020 Sep 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-1091
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.