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出境医 / 临床实验 / The Therapeutic Effect of Exercise Training on Patients With Dementia

The Therapeutic Effect of Exercise Training on Patients With Dementia

Study Description
Brief Summary:
This study aimed to clarify whether strength training or aerobic training could bring more benefits for patients with dementia

Condition or disease Intervention/treatment Phase
Dementia Device: Strength training Device: Aerobic training Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: comparison of therapeutic effect between aerobic and strength training on dementia patient
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Therapeutic Effect of Exercise Training on Old Patients With Dementia: A Randomized Controlled Trial
Actual Study Start Date : April 9, 2018
Actual Primary Completion Date : December 26, 2018
Actual Study Completion Date : December 26, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: Strength training
Muscle strength training programs
 Device: Strength training
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
Experimental: Aerobic training
Aerobic training programs
 Device: Aerobic 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
Outcome Measures
Primary Outcome Measures :
  1. Barthel index [ Time Frame: 4 weeks ]
    To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome

  2. Mini-mental state examination [ Time Frame: 4 weeks ]
    To evaluate cognitive function, range from 0-30, higher values represent a better outcome

  3. Montreal Cognitive Assessment [ Time Frame: 4 weeks ]
    To evaluate cognitive function, range from 0-30, higher values represent a better outcome

  4. Geriatric Depression Scale [ Time Frame: 4 weeks ]
    To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome


Secondary Outcome Measures :
  1. Concentration of serum brain derived neurotrophic factor (BDNF) [ Time Frame: 4 weeks ]
    Increasing BDNF level is related to preventing neurodegeneration.

  2. Concentration of plasma insulin-like growth factor-1 (IGF-1) [ Time Frame: 4 weeks ]
    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.

  3. Concentration of plasmamonocyte chemotactic protein-1 (MCP-1) [ Time Frame: 4 weeks ]
    The elevation of MCP-1 concentration usually means the progression of systemic inflammation.


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
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Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
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Principal Investigator: Yuan-Yang Cheng, MDPHD Department of rehabilitation of Taichung Veterans General Hospital
Tracking Information
First Submitted Date  ICMJE January 13, 2019
First Posted Date  ICMJE January 22, 2019
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE April 9, 2018
Actual Primary Completion Date December 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Barthel index [ Time Frame: 4 weeks ]
    To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome
  • Mini-mental state examination [ Time Frame: 4 weeks ]
    To evaluate cognitive function, range from 0-30, higher values represent a better outcome
  • Montreal Cognitive Assessment [ Time Frame: 4 weeks ]
    To evaluate cognitive function, range from 0-30, higher values represent a better outcome
  • Geriatric Depression Scale [ Time Frame: 4 weeks ]
    To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Concentration of serum brain derived neurotrophic factor (BDNF) [ Time Frame: 4 weeks ]
    Increasing BDNF level is related to preventing neurodegeneration.
  • Concentration of plasma insulin-like growth factor-1 (IGF-1) [ Time Frame: 4 weeks ]
    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) [ Time Frame: 4 weeks ]
    The elevation of MCP-1 concentration usually means the progression of systemic inflammation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Therapeutic Effect of Exercise Training on Patients With Dementia
Official Title  ICMJE The Therapeutic Effect of Exercise Training on Old Patients With Dementia: A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
comparison of therapeutic effect between aerobic and strength training on dementia patient
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dementia
Intervention  ICMJE
  • Device: Strength training
    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
  • Device: Aerobic 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
Study Arms  ICMJE
  • Experimental: Strength training
    Muscle strength training programs
    Intervention: Device: Strength training
  • Experimental: Aerobic training
    Aerobic training programs
    Intervention: Device: Aerobic training
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2019) 		61
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 26, 2018
Actual Primary Completion Date December 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 100 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03811314
Other Study ID Numbers  ICMJE CF18010B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taichung Veterans General Hospital
Study Sponsor  ICMJE Taichung Veterans General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuan-Yang Cheng, MDPHD Department of rehabilitation of Taichung Veterans General Hospital
PRS Account Taichung Veterans General Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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