Clinical trial NCT06094413: Effects of Multicomponent Training in Older Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Multicomponent Physical Activity
Older Adult
Quality of Life
Fear of Falling
Physical Performance
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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:

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.

Eligibility criteria: Inclusion Criteria:

* age greater than or equal to 65 years
* able and willing to provide consent
* patient of Geisinger 65Forward Scranton clinic

Exclusion Criteria:

* 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

Primary outcomes:
measure: Short Physical Performance Battery (SPPB) composite score
timeFrame: Prior to the start of the intervention (Week 1), Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
measure: Falls Efficacy Scale (FES) score
timeFrame: Prior to the start of the intervention (Week 1), Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
measure: Sarcopenia Quality of Life (SarQoL) score
timeFrame: 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:
measure: Hand Grip Strength score
timeFrame: Pre-intervention during the screening process, Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
Other outcomes:
measure: Qualitative Data from semi-structured interviews
timeFrame: Following completion of the intervention (Week 8)
Locations:
city: Scranton
country: United States
facility: Geisinger 65Forward
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Brenda Goodrich, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: East Stroudsburg University
name: Shala Davis, PhD
role: STUDY_CHAIR
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