Clinical trial NCT03811314: The Therapeutic Effect of Exercise Training on Patients With Dementia and Mild Cognitive Impairment
Official title: The Therapeutic Effect of Exercise Training on Old Patients With Dementia and Mild Cognitive Impairment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 107
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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

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. 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.

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
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.

Primary outcomes:
measure: Barthel index
timeFrame: 4 weeks
measure: Mini-mental state examination
timeFrame: 4 weeks
measure: Montreal Cognitive Assessment
timeFrame: 4 weeks
measure: Geriatric Depression Scale
timeFrame: 4 weeks
measure: Timed up and go test
timeFrame: 4 weeks
measure: SF-36
timeFrame: 4 weeks
Secondary outcomes:
measure: Concentration of serum brain derived neurotrophic factor (BDNF)
timeFrame: 4 weeks
measure: Concentration of plasma insulin-like growth factor-1 (IGF-1)
timeFrame: 4 weeks
measure: Concentration of plasmamonocyte chemotactic protein-1 (MCP-1)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Department of rehabilitation of Taichung Veterans General Hospital
name: Yuan-Yang Cheng, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
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.