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Completed

NCT Number: NCT06094413

Effects of Multicomponent Training in 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger 65Forward

Scranton, Pennsylvania, 18508, United States

About this study

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:

  • 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?

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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