Effects of Multicomponent Training on Sarcopenia

Sponsor

Geisinger Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06094413

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia	Behavioral: Multicomponent Training Intervention	N/A

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 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:

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?

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

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A mixed-methods study design will be used to assess the effectiveness of a multicomponent training program on quality of life, fear of falling, and physical performance in older adults with probable sarcopenia. The study includes a pre-mid-post-test design with an intervention group who will perform an 8-week multicomponent training program and a comparison group composed of patients who do not perform the intervention.A mixed-methods study design will be used to assess the effectiveness of a multicomponent training program on quality of life, fear of falling, and physical performance in older adults with probable sarcopenia. The study includes a pre-mid-post-test design with an intervention group who will perform an 8-week multicomponent training program and a comparison group composed of patients who do not perform the intervention.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effects of an 8-week Multicomponent Training Program on Quality of Life, Fear of Falling, & Physical Performance in Community-Dwelling Older Adults With Probable Sarcopenia

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multicomponent Training Intervention Subjects in the intervention group will attend two standardized group-based sixty-minute sessions per week in the outpatient medical center and will be asked not to change their current physical activity regimen during the 8-week duration of the study.	Behavioral: Multicomponent Training Intervention The intervention will be 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 will consist of three phases: warm-up/initiation, conditioning, and cooldown. The intervention will be composed of aerobic, resistance, balance, and flexibility exercises. At each session subjects will be informed of the program goals and the methods used to document exercise tolerance of the session's training loads. The quality of the intervention will be measured by patient compliance, adherence, and feedback such as rates of perceived exertion (RPE) which will be documented during the session to measure immediate effect of the intervention. Progressions will be guided by individual responsiveness and measured by RPE. Progressions will be based on the training principles of specificity, adaptability, and overload.
No Intervention: Control Group Subjects in the control group will be asked to not change their current level of physical activity during the 8-week duration of the study.

Arm

Intervention/Treatment

Experimental: Multicomponent Training Intervention

Subjects in the intervention group will attend two standardized group-based sixty-minute sessions per week in the outpatient medical center and will be asked not to change their current physical activity regimen during the 8-week duration of the study.

Behavioral: Multicomponent Training Intervention

The intervention will be 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 will consist of three phases: warm-up/initiation, conditioning, and cooldown. The intervention will be composed of aerobic, resistance, balance, and flexibility exercises. At each session subjects will be informed of the program goals and the methods used to document exercise tolerance of the session's training loads. The quality of the intervention will be measured by patient compliance, adherence, and feedback such as rates of perceived exertion (RPE) which will be documented during the session to measure immediate effect of the intervention. Progressions will be guided by individual responsiveness and measured by RPE. Progressions will be based on the training principles of specificity, adaptability, and overload.

No Intervention: Control Group

Subjects in the control group will be asked to not change their current level of physical activity during the 8-week duration of the study.

Outcome Measures

Primary Outcome Measures

Sarcopenia Quality of Life (SarQoL) score [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 assesses perceived domains such as physical & mental health, fears, and functionality in daily life. Each domain is scored from 0-100 and an Overall Score is calculated. The total scoring ranges from 0(worst imaginable health) to 100 (best imaginable health).
Falls Efficacy Scale-International (FES-I) score [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-I is a tool that was developed to assess self-confidence while performing physical activity in conjunction with a fear of falling.The questionnaire consists of 16 items that assess the physical, social, and functional aspects related to the fear of falling. The FES-I score ranges from 16 (complete absence of fear of falling) to 64 (extreme concern) points.
Short Physical Performance Battery (SPPB) composite score [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 is 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.

Secondary Outcome Measures

Hand Grip Strength score [Pre-intervention during the screening process, Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)]
A hand dynamometer will be used to assess hand grip strength in both upper extremities. The instrument score is calculated in kg (0-90) with a lower score indicating lower hand grip strength and a higher score indicating higher hand grip strength.

Other Outcome Measures

Qualitative Data from semi-structured interviews [Following completion of the intervention (Week 8)]
Post-intervention interviews will be completed after completion of the 8-week intervention by willing subjects to identify drivers, barriers, and satisfaction levels for participants. Interviews will be 15 minutes in length, held in the same area as the intervention, recorded through Zoom communication platform, and then transcribed for qualitative analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age greater than or equal to 65 years
a score greater than 4 on the the Strength, Assistance with walking, Rising from a chair, Climbing stairs and Falls questionnaire (SARC-F)
hand grip strength test includes a score of less than 27kg for males and less than 16 kg for females
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
Current participation in a structured exercise training program
An inability to perform an exercise program independently