The Therapeutic Effect of Exercise Training on Patients With Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Strength training
Aerobic training
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Dementia
Eligibility Criteria
Inclusion criteria:
- Patients aged above 65 years old
- Patients with mild dementia with Mini-mental state examination scoring 15 to 26
Exclusion criteria:
- 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.
Sites / Locations
- Taichung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Strength training
Aerobic training
Arm Description
Muscle strength training programs
Aerobic training programs
Outcomes
Primary Outcome Measures
Barthel index
To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome
Mini-mental state examination
To evaluate cognitive function, range from 0-30, higher values represent a better outcome
Montreal Cognitive Assessment
To evaluate cognitive function, range from 0-30, higher values represent a better outcome
Geriatric Depression Scale
To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome
Secondary Outcome Measures
Concentration of serum brain derived neurotrophic factor (BDNF)
Increasing BDNF level is related to preventing neurodegeneration.
Concentration of plasma insulin-like growth factor-1 (IGF-1)
Lower plasma level of IGF-1 is associated with an increased risk of developing Alzheimer's dementia, and higher levels of it may protect against neurodegeneration.
Concentration of plasmamonocyte chemotactic protein-1 (MCP-1)
The elevation of MCP-1 concentration usually means the progression of systemic inflammation.
Full Information
NCT ID
NCT03811314
First Posted
January 13, 2019
Last Updated
January 20, 2019
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03811314
Brief Title
The Therapeutic Effect of Exercise Training on Patients With Dementia
Official Title
The Therapeutic Effect of Exercise Training on Old Patients With Dementia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
December 26, 2018 (Actual)
Study Completion Date
December 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to clarify whether strength training or aerobic training could bring more benefits for patients with dementia
Detailed Description
Exercise training has been evidenced to bring various of benefits for patients with dementia in past studies. However, whether strength training or aerobic training could bring better benefits has not been confirmed in the past. This study designed to recruit 30 patients with mild dementia in the first year. Every patient will receive strength training using dumbbells, butterfly machine and vertical leg press machine for four weeks. Outcome measures including self care ability, cognitive function, MCP-1, BDNF and IGF-1 levels, and the degree of depression will be recorded before and after the training. In the second year, the investigators also designed to recruit 31 patients with mild dementia. These participants will instead receive aerobic training using stationary bicycle for four weeks. The same outcome measures will be tested as in the first year. Via the results of this study, whether strength training or aerobic training could bring better benefits in dementia patient can thus be elucidated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
comparison of therapeutic effect between aerobic and strength training on dementia patient
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strength training
Arm Type
Experimental
Arm Description
Muscle strength training programs
Arm Title
Aerobic training
Arm Type
Experimental
Arm Description
Aerobic training programs
Intervention Type
Device
Intervention Name(s)
Strength training
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Aerobic training
Intervention Description
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
Primary Outcome Measure Information:
Title
Barthel index
Description
To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome
Time Frame
4 weeks
Title
Mini-mental state examination
Description
To evaluate cognitive function, range from 0-30, higher values represent a better outcome
Time Frame
4 weeks
Title
Montreal Cognitive Assessment
Description
To evaluate cognitive function, range from 0-30, higher values represent a better outcome
Time Frame
4 weeks
Title
Geriatric Depression Scale
Description
To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Concentration of serum brain derived neurotrophic factor (BDNF)
Description
Increasing BDNF level is related to preventing neurodegeneration.
Time Frame
4 weeks
Title
Concentration of plasma insulin-like growth factor-1 (IGF-1)
Description
Lower plasma level of IGF-1 is associated with an increased risk of developing Alzheimer's dementia, and higher levels of it may protect against neurodegeneration.
Time Frame
4 weeks
Title
Concentration of plasmamonocyte chemotactic protein-1 (MCP-1)
Description
The elevation of MCP-1 concentration usually means the progression of systemic inflammation.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Patients aged above 65 years old
Patients with mild dementia with Mini-mental state examination scoring 15 to 26
Exclusion criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan-Yang Cheng, MDPHD
Organizational Affiliation
Department of rehabilitation of Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
32084347
Citation
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.
Results Reference
derived
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The Therapeutic Effect of Exercise Training on Patients With Dementia
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