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Clinical Trial Summary

The purpose of the study is to determine whether community-dwelling older adults with probable sarcopenia (muscle loss) will experience improved patient-reported outcomes and physical performance after completing an 8-week multicomponent exercise training program when compared to a control group who does not complete the intervention. As an additional aim, subjects who participate in the exercise intervention will be asked about their experiences to identify factors that contribute to positive health behaviors in community-dwelling older adults.


Clinical Trial 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 shown to be a precursor to falls, disability, and mortality. Exercise is a non-pharmacological intervention that has been shown to prevent and manage the progression of sarcopenia, 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 with probable sarcopenia. A convenient sample of community-dwelling older adults aged 65 years and older referred by a physician from an outpatient medical center in Northeast Pennsylvania will be assessed for "probable sarcopenia" and recruited to participate. Eligible subjects will be randomly assigned to an intervention group who will attend two group-based sixty-minute standardized sessions per week supervised by an experienced professional in the outpatient medical center or a comparison group composed of patients who did not perform the intervention. Outcomes testing will occur 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 complete the intervention will be conducted by the researcher in the designated research environment to assess barriers, drivers, and the overall experience of the intervention. The study will evaluate 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? Data analysis will include a two-way ANOVA to determine between-group effects and an ANCOVA to calculate for other factors such as important group characteristics at baseline. A Tukey post hoc test will be used to evaluate where differences occur (pre-, mid-, post-). General ideas and emerging themes will be inductively coded by the researcher from the post-intervention interview transcripts. The duration of the study is expected to be sixteen weeks and is dependent upon the recruitment process. The study is significant because it will assess whether the program is a feasible intervention that can be implemented by providers to aid in the management of probable sarcopenia for community-dwelling older adults. The findings of this study will offer providers evidence-based practices that can be used for effective multicomponent exercise training prescription. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06094413
Study type Interventional
Source Geisinger Clinic
Contact
Status Enrolling by invitation
Phase N/A
Start date March 4, 2024
Completion date August 2024

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