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DementiaNCT06637228

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

A study testing Move Your Hands, Feet, and Brain: Integrated Exercise Intervention Based on Taipei City Elderly Physical Activity Guidelines in people with Dementia and Depressive Symptoms, run by Chang Gung University of Science and Technology at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 90 years
What is being tested?
Move Your Hands, Feet, and Brain: Integrated Exercise Intervention Based on Taipei City Elderly Physical Activity Guidelines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesTaiwan
Study dates
22 Sep 2023to 3 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Dementia Care Center, Tungs' Taichung Metroharbor Hospital

    Taichung, 433

  • Taoyuan Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: 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:

  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?
Read more

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.

Being tested
Move Your Hands, Feet, and Brain: Integrated Exercise Intervention Based on Taipei City Elderly Physical Activity Guidelines
Keywords
dementia, older adults, sarcopenia, depression symptoms, quality of life, integrated exercise, cognitive function, geriatric care, health outcomes
Medical subject headings
Dementia, Depression, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT06637228
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: Move Your Hands, Feet, and Brain: Integrated Exercise Intervention Based on Taipei City Elderly Physical Activity Guidelines
Control GroupNo interventionThe control group continued with their usual treatment and daily activities.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (2)

  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start22 Sep 2023
  3. Primary completion3 Jun 2024
  4. Study completion3 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06637228
Sponsor's protocol ID
ZRRPF3N0031
Other IDs
TTMHH-R1130034
Status last verified
Oct 2024
First submitted
9 Oct 2024
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Move Your Hands, Feet, and Brain: Integrated Exercise Intervention Based on Taipei City Elderly Physical Activity Guidelines in people with Dementia and Depressive Symptoms, run by Chang Gung University of Science and Technology at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sarcopenia Improvement (time frame: Baseline Assessment: 0 weeks (Pre-intervention); Post-Intervention Assessment: 12 weeks (Post-intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06637228, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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