An interventional study of Multicomponent Training Intervention in Sarcopenia, sponsored by Geisinger Clinic. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Geisinger Clinic · Not applicable, Interventional, and Supportive care
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.
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:
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.
1,208 studies on the registry are indexed under Sarcopenia; 401 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 773 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Geisinger Clinic is the lead sponsor of 125 studies on the registry; 21 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Multicomponent Training 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.
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.
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.
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)
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.
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)
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).
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)
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.
Time frame: Pre-intervention during the screening process, Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
Qualitative Data from semi-structured interviews
Post-intervention interviews were completed after completion of the 8-week intervention by willing subjects to identify drivers, barriers, and satisfaction levels for participants. Interviews were 15 minutes in length, held in the same area as the intervention, recorded through Zoom communication platform, and then transcribed for qualitative analysis.
Time frame: Following completion of the intervention (Week 8)
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Geisinger Clinic