CClinicalTrials.gg
CompletedNCT06637228Updated Oct 15, 2024

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

An interventional study of Move Your Hands, Feet, and Brain: Integrated Exercise Intervention Based on Taipei City Elderly Physical Activity Guidelines in Dementia, Depressive Symptoms and Quality of Life (QOL), sponsored by Chang Gung University of Science and Technology. Completed at 2 sites in Taiwan. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Chang Gung University of Science and Technology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Sep 2023, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
65 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 80 is close to the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Chang Gung University of Science and Technology is the lead sponsor of 41 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • 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.

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

  • No intervention
    Control Group

    The control group continued with their usual treatment and daily activities.

Interventions

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

    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.

06

What researchers measure

Primary outcomes

  1. Sarcopenia Improvement

    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).

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

Secondary outcomes

  1. Depression Symptoms

    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.

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

  2. Quality of Life

    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.

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

07

Study locations

2 sites
  • Dementia Care Center, Tungs' Taichung Metroharbor Hospital
    Taichung, 433, Taiwan
  • Taoyuan Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
08

References and documents

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. PubMed 34029642 ↗
  • 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. PubMed 37703691 ↗
  • 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. PubMed 36186132 ↗
  • 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. PubMed 36837864 ↗
  • 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. PubMed 34179935 ↗
  • 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. PubMed 38112863 ↗
  • 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. PubMed 37139947 ↗
  • 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. PubMed 33397453 ↗
  • 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. PubMed 35782450 ↗
  • 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. PubMed 30276173 ↗
  • 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. PubMed 37057640 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06637228
Lead sponsor
Chang Gung University of Science and Technology
Collaborators
Tungs' Taichung Metroharbor Hospital
Responsible party
Yu-Nu Wang (Associate Professor, Chang Gung University of Science and Technology) — Principal investigator
First posted
Oct 15, 2024
Start date
Sep 22, 2023
Primary completion
Jun 3, 2024
Completion
Jun 3, 2024
Last update
Oct 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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