- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06637228
Effects of Integrated Exercise on Sarcopenia, Depression Symptoms, and Quality of Life
Effects of Integrated Exercise on Sarcopenia, Depression Symptoms, and Quality of Life of Community-Dwelling Older Adults With Dementia
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:
- Does the integrated exercise intervention improve muscle mass and strength in older adults with dementia?
- How does the intervention affect the participants' depression symptoms?
- What changes occur in the quality of life of participants following the exercise program?
In this study, participants will:
- Be divided into two groups: an integrated exercise group and a control group.
- 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.
- 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.
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taichung, Taiwan, 433
- Dementia Care Center, Tungs' Taichung Metroharbor Hospital
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Taoyuan, Taiwan, 333
- Taoyuan Chang Gung Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
Participants in the intervention group engaged in a structured integrated exercise program designed to improve physical function and emotional well-being.
The program lasted for 12 weeks, with sessions held three times a week.
Each session lasted for 50 minutes and included a combination of strength training, aerobic exercises, stretching, and balance activities.
The exercise regimen aimed to enhance muscle strength, endurance, flexibility, and overall quality of life, specifically targeting the symptoms of sarcopenia and depression.
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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. |
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No Intervention: Control Group
The control group continued with their usual treatment and daily activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sarcopenia Improvement
Time Frame: Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)
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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).
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Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Depression Symptoms
Time Frame: Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)
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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.
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Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)
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Quality of Life
Time Frame: Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)
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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.
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Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Escriche-Escuder A, Fuentes-Abolafio IJ, Roldan-Jimenez C, Cuesta-Vargas AI. Effects of exercise on muscle mass, strength, and physical performance in older adults with sarcopenia: A systematic review and meta-analysis according to the EWGSOP criteria. Exp Gerontol. 2021 Aug;151:111420. doi: 10.1016/j.exger.2021.111420. Epub 2021 May 23.
- Silva AC, Pereira MA, Peixoto LM, Rosse IC, Junior JBF, de Oliveira EC, Becker LK, Coelho DB. 12 weeks of resistance training with progressive intensity improves the diagnostic parameters of sarcopenia in individuals of advanced age. Geriatr Nurs. 2023 Nov-Dec;54:60-65. doi: 10.1016/j.gerinurse.2023.08.015. Epub 2023 Sep 11.
- Gonzalez-Rocha A, Mendez-Sanchez L, Ortiz-Rodriguez MA, Denova-Gutierrez E. Effect Of Exercise on Muscle Mass, Fat Mass, Bone Mass, Muscular Strength and Physical Performance in Community Dwelling Older Adults: Systematic Review and Meta-Analysis. Aging Dis. 2022 Oct 1;13(5):1421-1435. doi: 10.14336/AD.2022.0215. eCollection 2022 Oct 1.
- Lin A, Wang T, Li C, Pu F, Abdelrahman Z, Jin M, Yang Z, Zhang L, Cao X, Sun K, Hou T, Liu Z, Chen L, Chen Z. Association of Sarcopenia with Cognitive Function and Dementia Risk Score: A National Prospective Cohort Study. Metabolites. 2023 Feb 8;13(2):245. doi: 10.3390/metabo13020245.
- Wang LT, Huang WC, Hung YC, Park JH. Association between Depressive Symptoms and Risk of Sarcopenia in Taiwanese Older Adults. J Nutr Health Aging. 2021;25(6):790-794. doi: 10.1007/s12603-021-1631-5.
- Barros D, Borges-Machado F, Silva-Fernandes A, Ribeiro O, Carvalho J. Do physical fitness and cognitive function mediate the relationship between basic activities of daily living and quality of life in older adults with dementia? Qual Life Res. 2024 Apr;33(4):917-926. doi: 10.1007/s11136-023-03570-3. Epub 2023 Dec 19.
- Beaudart C, Demonceau C, Reginster JY, Locquet M, Cesari M, Cruz Jentoft AJ, Bruyere O. Sarcopenia and health-related quality of life: A systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2023 Jun;14(3):1228-1243. doi: 10.1002/jcsm.13243. Epub 2023 May 4.
- Faieta JM, Devos H, Vaduvathiriyan P, York MK, Erickson KI, Hirsch MA, Downer BG, van Wegen EEH, Wong DC, Philippou E, Negm A, Ahmadnezhad P, Krishnan S, Kahya M, Sood P, Heyn PC. Exercise interventions for older adults with Alzheimer's disease: a systematic review and meta-analysis protocol. Syst Rev. 2021 Jan 4;10(1):6. doi: 10.1186/s13643-020-01555-8.
- Liu W, Zhang J, Wang Y, Li J, Chang J, Jia Q. Effect of Physical Exercise on Cognitive Function of Alzheimer's Disease Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trial. Front Psychiatry. 2022 Jun 16;13:927128. doi: 10.3389/fpsyt.2022.927128. eCollection 2022.
- Yoo SZ, No MH, Heo JW, Park DH, Kang JH, Kim SH, Kwak HB. Role of exercise in age-related sarcopenia. J Exerc Rehabil. 2018 Aug 24;14(4):551-558. doi: 10.12965/jer.1836268.134. eCollection 2018 Aug.
- Shen Y, Shi Q, Nong K, Li S, Yue J, Huang J, Dong B, Beauchamp M, Hao Q. Exercise for sarcopenia in older people: A systematic review and network meta-analysis. J Cachexia Sarcopenia Muscle. 2023 Jun;14(3):1199-1211. doi: 10.1002/jcsm.13225. Epub 2023 Apr 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZRRPF3N0031
- TTMHH-R1130034 (Other Grant/Funding Number: Tungs' Taichung Metroharbor Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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