Viewing Study NCT06094413



Ignite Creation Date: 2024-05-06 @ 7:40 PM
Last Modification Date: 2024-10-26 @ 3:11 PM
Study NCT ID: NCT06094413
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2024-05-21
First Post: 2023-10-16

Brief Title: Effects of Multicomponent Training in Older Adults
Sponsor: Geisinger Clinic
Organization: Geisinger Clinic

Study Overview

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
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 shown to be a precursor to 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 referred by a physician from an outpatient medical center in Northeast Pennsylvania will be 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 comparison 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

Data analysis included a repeated-measures ANOVA and one-way ANOVA to determine between-group effects A Tukey post hoc test 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 duration of the study was expected to be sixteen weeks and was dependent upon the recruitment process 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 mass and strength 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None