The Therapeutic Effect of Exercise Training on Patients With Dementia and Mild Cognitive Impairment

Dementia Clinical Trial

Official title:

The Therapeutic Effect of Exercise Training on Old Patients With Dementia and Mild Cognitive Impairment: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03811314
• Other study ID #: CF18010B
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: December 26, 2023

Study information

• Verified date: February 2024
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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. The other part of the study recruited 46 patients with mild cognitive impairment, who were randomized into either a four-week isokinetic or isotonic training program. All cases were evaluated by isokinetic peak torque, 36-item Short Form Survey (SF-36), Mini-Mental State Examination (MMSE), Barthel Index, geriatric depression scale (GDS-15), and Timed Up and Go test (TUG test) before and after each kind of training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 26, 2023
• Est. primary completion date: December 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

Inclusion criteria:

1. Patients aged above 65 years old

2. Patients with mild dementia with Mini-mental state examination scoring 15 to 26

3. Another arm is patients with mild cognitive impairment and Mini-mental state examination scoring 23 to 27

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia

Intervention

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
• 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
• Isokinetic trinaing
Using Biodex isokinetic dynanometer and set it in isokinetic mode in 60 degree per second
• Isotonic training
Using Biodex isokinetic dynanometer and set it in isotonic mode at 60% of the maximal peak torque

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barthel index	To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome	4 weeks
Primary	Mini-mental state examination	To evaluate cognitive function, range from 0-30, higher values represent a better outcome	4 weeks
Primary	Montreal Cognitive Assessment	To evaluate cognitive function, range from 0-30, higher values represent a better outcome	4 weeks
Primary	Geriatric Depression Scale	To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome	4 weeks
Primary	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
Primary	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	Concentration of serum brain derived neurotrophic factor (BDNF)	Increasing BDNF level is related to preventing neurodegeneration.	4 weeks
Secondary	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.	4 weeks
Secondary	Concentration of plasmamonocyte chemotactic protein-1 (MCP-1)	The elevation of MCP-1 concentration usually means the progression of systemic inflammation.	4 weeks