The Therapeutic Effect of Exercise Training on Old Patients With Dementia: A Randomized Controlled Trial
The Therapeutic Effect of Exercise Training on Patients With Dementia
Sponsors
Source
Taichung Veterans General Hospital
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Completed
Start Date
2018-04-09
Completion Date
2018-12-26
Primary Completion Date
2018-12-26
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Barthel index |
4 weeks |
|
Mini-mental state examination |
4 weeks |
|
Montreal Cognitive Assessment |
4 weeks |
|
Geriatric Depression Scale |
4 weeks |
Secondary Outcome
Measure |
Time Frame |
|
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 |
Enrollment
61
Condition
Intervention
Intervention Type
Device
Intervention Name
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
Arm Group Label
Strength training
Intervention Type
Device
Intervention Name
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
Arm Group Label
Aerobic training
Eligibility
Criteria
Inclusion criteria:
1. Patients aged above 65 years old
2. Patients with mild dementia with Mini-mental state examination scoring 15 to 26
Exclusion criteria:
1. Cardiopulmonary diseases or orthopedical conditions that prohibit the patient from
receiving exercise training of our programs
2. Cognitive problems that impede the patient to understand and answer the content of our
questionnaires.
Gender
All
Minimum Age
65 Years
Maximum Age
100 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Yuan-Yang Cheng, MDPHD |
Principal Investigator |
Department of rehabilitation of Taichung Veterans General Hospital |
Location
Facility |
|
Taichung Veterans General Hospital Taichung 40705 Taiwan |
Location Countries
Country
Taiwan
Verification Date
2019-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Strength training
Arm Group Type
Experimental
Description
Muscle strength training programs
Arm Group Label
Aerobic training
Arm Group Type
Experimental
Description
Aerobic training programs
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
comparison of therapeutic effect between aerobic and strength training on dementia patient
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)
Study First Submitted
January 13, 2019
Study First Submitted Qc
January 17, 2019
Study First Posted
January 21, 2019
Last Update Submitted
January 20, 2019
Last Update Submitted Qc
January 20, 2019
Last Update Posted
January 23, 2019
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.