Effects of Multicomponent Training in Older Adults

NCT06094413 | Completed

• 1 other identifier: 2023-1091
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Multicomponent Physical Activity; Older Adult; Quality of Life; Fear of Falling; Physical Performance

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  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 (1)

• 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)

Other Outcomes (1)

• Qualitative Data from semi-structured interviews

  Following completion of the intervention (Week 8)

Study Arms (2)

Multicomponent Training Intervention

EXPERIMENTAL

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

Control Group

NO 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.

Interventions

Multicomponent Training Intervention BEHAVIORAL

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.

Multicomponent Training Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger 65Forward

Scranton, Pennsylvania, 18508, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Brenda Goodrich, DO

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

• Shala Davis, PhD

  East Stroudsburg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: March 4, 2024
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)