NCT06637228

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. 1.Does the integrated exercise intervention improve muscle mass and strength in older adults with dementia?
  2. 2.How does the intervention affect the participants' depression symptoms?
  3. 3.What changes occur in the quality of life of participants following the exercise program?
  4. 4.Be divided into two groups: an integrated exercise group and a control group.
  5. 5.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.
  6. 6.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

October 9, 2024

Last Update Submit

October 9, 2024

Conditions

Keywords

dementiaolder adultssarcopeniadepression symptomsquality of lifeintegrated exercisecognitive functiongeriatric carehealth outcomes

Outcome Measures

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).

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

Secondary Outcomes (2)

  • Depression Symptoms

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

  • Quality of Life

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

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.

Intervention Group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dementia Care Center, Tungs' Taichung Metroharbor Hospital

Taichung, 433, Taiwan

Location

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (11)

  • 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.

MeSH Terms

Conditions

DementiaDepressionSarcopenia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 15, 2024

Study Start

September 22, 2023

Primary Completion

June 3, 2024

Study Completion

June 3, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations