Effects of Multicomponent Training in Older Adults

February 3, 2025 updated by: Geisinger Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Scranton, Pennsylvania, United States, 18508
        • Geisinger 65Forward

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery (SPPB) composite score
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)
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.
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
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)
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.
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
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)
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand Grip Strength score
Time Frame: Pre-intervention during the screening process, Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)
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.
Pre-intervention during the screening process, Mid-point of the intervention (Week 4), Following the completion of the Intervention (Week 8)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Data from semi-structured interviews
Time Frame: Following completion of the intervention (Week 8)
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.
Following completion of the intervention (Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Investigators

  • Principal Investigator: Brenda Goodrich, DO, Geisinger Clinic
  • Study Chair: Shala Davis, PhD, East Stroudsburg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Actual)

December 17, 2024

Study Completion (Actual)

December 17, 2024

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-1091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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