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NCT Number: NCT06637228

Effects of Integrated Exercise on Sarcopenia, Depression Symptoms, and Quality of Life

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.

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Key information

Conditions

Dementia Atrophy Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Depressive Symptoms Mental Disorders Muscular Atrophy Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Quality of Life (QOL) Sarcopenia Sarcopenia in Elderly Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dementia Care Center, Tungs' Taichung Metroharbor Hospital, Taichung, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Move Your Hands, Feet, and Brain: Integrated Exercise Intervention Based on Taipei City Elderly Physical Activity Guidelines

Behavioral

This video is tailored for fitness exercises for both healthy and sub-healthy elderly individuals and features various physical activity themes, including warm-up routines, balance and coordination drills, aerobic coordination exercises, strength training using chairs and water bottles, and cool-down routines. We selected a 3-month duration with sessions held three times a week to align with established effective intervention periods and to ensure participant adherence.

Integrated exercise sessions were conducted by the staff at the dementia care centers/service bases and lasted 50 minutes. Considering the impact of dementia and aging on the ability of older adults to engage in physical activities, the staff provided simple instructions, and participants performed the exercises while seated to prevent falls. Meanwhile, the control group continued with their usual treatment and daily activities.

Primary outcomes

  1. Sarcopenia Improvement

    Time frame: Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)

    Participants were assessed for skeletal muscle mass, based on the skeletal muscle index (SMI), muscle strength, and physical performance using thresholds established by the AWGS to identify those with sarcopenia and group them as follows: possible sarcopenia (low muscle strength or low physical performance, only); sarcopenia (low SMI, and low muscle strength or low physical performance); and severe sarcopenia (low SMI, and low muscle strength, and low physical performance).

Secondary outcomes

  1. Depression Symptoms

    Time frame: Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)

    We used the Chinese version of the 20-item Center for Epidemiologic Studies Depression Scale (CES-D), validated by Cheng & Chan (2005). This scale measures the frequency of depressive symptoms over the past week, with responses ranging from 0 (less than 1 day) to 3 (5-7 days). Total scores range from 0 to 60, with higher scores indicating more severe depressive symptoms.

  2. Quality of Life

    Time frame: Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)

    We used the Taiwan version of the Medical Outcomes Study Short Form-36 (SF-36) scale (Tseng, et al., 2003) to assess quality of life, which follows a norm-based scoring method (Ware et al., 1994) and Taiwan-specific algorithms. Scores range from 0 to 100, with higher scores indicating better QoL.

Sponsors and collaborators

Lead sponsor

Chang Gung University of Science and Technology

Other

Collaborators

  • Tungs' Taichung Metroharbor Hospital

Registry information

Official study title

Effects of Integrated Exercise on Sarcopenia, Depression Symptoms, and Quality of Life of Community-Dwelling Older Adults With Dementia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

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

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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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