Clinical trial NCT06637228: Effects of Integrated Exercise on Sarcopenia, Depression Symptoms, and Quality of Life
Official title: Effects of Integrated Exercise on Sarcopenia, Depression Symptoms, and Quality of Life of Community-Dwelling Older Adults With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Depressive Symptoms
Quality of Life (QOL)
Sarcopenia in Elderly
Keywords: dementia
older adults
sarcopenia
depression symptoms
quality of life
integrated exercise
cognitive function
geriatric care
health outcomes
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Tungs' Taichung Metroharbor Hospital
First posted: 2024-10-15
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a parallel assignment model, consisting of two groups: an integrated exercise intervention group and a control group. Participants aged 65 years and older with a diagnosis of dementia were recruited from outpatient neurological/dementia clinics and community centers in Taiwan. The intervention group engaged in a 12-week structured exercise program that included strength training, aerobic exercise, stretching, and balance activities, meeting at least three times per week. In contrast, the control group continued their usual daily activities without any structured exercise regimen. Both groups were assessed at baseline and post-intervention to evaluate the effects of the integrated exercise on sarcopenia, depression symptoms, and quality of life.
Primary purpose: TREATMENT

Brief summary: The goal of this quasi-experimental (nonrandomized intervention) study is to investigate the effects of an integrated exercise intervention on sarcopenia, depression symptoms, and quality of life in community-dwelling older adults with dementia. The main questions it aims to answer are:

1. Does the integrated exercise intervention improve muscle mass and strength in older adults with dementia?
2. How does the intervention affect the participants' depression symptoms?
3. What changes occur in the quality of life of participants following the exercise program?

In this study, participants will:

1. Be divided into two groups: an integrated exercise group and a control group.
2. The intervention group will participate in a 12-week integrated exercise program consisting of strength training, aerobic exercise, stretching, and balance training, performed for 50 minutes at least three times a week.
3. Assessments will be conducted before the intervention and after 12 weeks, including body composition analysis, grip strength measurement, physical function tests, and structured questionnaires evaluating demographics, depression symptoms, and quality of life.

This study aims to determine the effectiveness of integrated exercise in addressing sarcopenia, alleviating depression symptoms, and enhancing the quality of life among older adults with dementia. The findings may provide valuable insights for developing community-based exercise interventions for this population.

Detailed description: This study explored the effects of an integrated exercise intervention on sarcopenia, depressive symptoms, and quality of life in community-dwelling older adults diagnosed with dementia. Sarcopenia, characterized by the loss of muscle mass and strength associated with aging, poses significant risks, including frailty, disability, and reduced quality of life, particularly among older adults.

Given the rising prevalence of dementia globally, addressing the effects of sarcopenia in this population was crucial. The proposed intervention involved a carefully structured exercise program tailored to enhance physical function and emotional health, incorporating elements of strength training, aerobic exercise, stretching, and balance activities.

Participants were recruited from outpatient neurological/dementia clinics and community centers in Taiwan, targeting individuals aged 65 and above. Selection was based on established eligibility criteria. Those assigned to the integrated exercise group engaged in a 12-week program, attending exercise sessions lasting 50 minutes at least three times per week. Meanwhile, the control group continued with their regular daily activities without any structured exercise regimen.

To assess the intervention's effectiveness, various outcome measures were utilized. These included evaluations of body composition, grip strength, and physical function, along with structured questionnaires to assess depressive symptoms and overall quality of life. Assessments took place at baseline and at the conclusion of the 12-week program, allowing for a comparison of pre- and post-intervention outcomes.

The findings from this study provided valuable insights into the role of structured physical activity in mitigating the effects of sarcopenia and enhancing mental health among older adults living with dementia. Ultimately, the results will inform the development of effective, community-based strategies aimed at improving the overall well-being of this vulnerable population.

Eligibility criteria: Inclusion Criteria:

* Older adults with dementia were eligible to enroll in the study if they met the following inclusion criteria: 1) age of 65 years or older, 2) diagnosed with dementia by a neurologist, 3) able to walk independently (with or without a cane), 4) having measurable grip strength on at least one hand, 5) and having a score on the Clinical Dementia Rating (CDR) scale ≤ 2.

Exclusion Criteria:

* Individuals at risk of falling, unable to communicate or complete the sarcopenia test, under guardianship, any major psychiatric disorder, or any cognitive disability or impairment that prevented meaningful communication were excluded.

Primary outcomes:
measure: Sarcopenia Improvement
timeFrame: Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)
Secondary outcomes:
measure: Depression Symptoms
timeFrame: Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)
measure: Quality of Life
timeFrame: Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Dementia Care Center, Tungs' Taichung Metroharbor Hospital
city: Taoyuan
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
Study officials:
References:
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