NCT03811314

Brief Summary

This study aimed to clarify whether strength training or aerobic training could bring more benefits for patients with dementia, another study is to clarify whether isokinetic or isotonic training could bring more benefits for patients with mild cognitive impairment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

April 9, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

5.7 years

First QC Date

January 13, 2019

Last Update Submit

February 26, 2024

Conditions

Keywords

Dementia

Outcome Measures

Primary Outcomes (6)

  • Barthel index

    To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome

    4 weeks

  • Mini-mental state examination

    To evaluate cognitive function, range from 0-30, higher values represent a better outcome

    4 weeks

  • Montreal Cognitive Assessment

    To evaluate cognitive function, range from 0-30, higher values represent a better outcome

    4 weeks

  • Geriatric Depression Scale

    To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome

    4 weeks

  • Timed up and go test

    Measure the time taken by a patient to stand up from a chair, walk three meters, return, and sit back on the chair

    4 weeks

  • SF-36

    consists of 36 questions categorized into 8 subdomains, including physical functioning, role limitations due to physical health, pain, general health condition, vitality, social functioning, role limitations due to emotional problems, and emotional well-being.

    4 weeks

Secondary Outcomes (3)

  • Concentration of serum brain derived neurotrophic factor (BDNF)

    4 weeks

  • Concentration of plasma insulin-like growth factor-1 (IGF-1)

    4 weeks

  • Concentration of plasmamonocyte chemotactic protein-1 (MCP-1)

    4 weeks

Study Arms (4)

Strength training

EXPERIMENTAL

Muscle strength training programs

Device: Strength training

Aerobic training

EXPERIMENTAL

Aerobic training programs

Device: Aerobic training

Isokinetic training

EXPERIMENTAL

Isokinetic training

Device: Isokinetic trinaing

Isotonic training

EXPERIMENTAL

Isotonic training

Device: Isotonic training

Interventions

Using dumbbells, butterfly machine and vertical leg press machine for strength training, 12 repetition maximum weight for 12 repetition, three times a day, five days a week, for a total of four weeks

Strength training

Using stationary bicycle to perform cardiopulmonary endurance training in 50-70 heart rate reserve for 20 minutes, five days per week, for a total of four weeks

Aerobic training

Using Biodex isokinetic dynanometer and set it in isokinetic mode in 60 degree per second

Isokinetic training

Using Biodex isokinetic dynanometer and set it in isotonic mode at 60% of the maximal peak torque

Isotonic training

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged above 65 years old
  • Patients with mild dementia with Mini-mental state examination scoring 15 to 26
  • Another arm is patients with mild cognitive impairment and Mini-mental state examination scoring 23 to 27

You may not qualify if:

  • Cardiopulmonary diseases or orthopedical conditions that prohibit the patient from receiving exercise training of our programs
  • Cognitive problems that impede the patient to understand and answer the content of our questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Related Publications (1)

  • Liu IT, Lee WJ, Lin SY, Chang ST, Kao CL, Cheng YY. Therapeutic Effects of Exercise Training on Elderly Patients With Dementia: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 May;101(5):762-769. doi: 10.1016/j.apmr.2020.01.012. Epub 2020 Feb 19.

MeSH Terms

Conditions

Dementia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yuan-Yang Cheng, MDPHD

    Department of rehabilitation of Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: comparison of therapeutic effect between aerobic and strength training on dementia patient, and comparison of therapeutic effect between isokinetic and isotonic training on patients with mild cognitive impairment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2019

First Posted

January 22, 2019

Study Start

April 9, 2018

Primary Completion

December 26, 2023

Study Completion

December 26, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations