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NCT Number: NCT03811314

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

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

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged above 65 years old
  • Patients with mild dementia with Mini-mental state examination scoring 15 to 26
  • Another arm is patients with mild cognitive impairment and Mini-mental state examination scoring 23 to 27

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.

Treatment and study plan

Strength training

Device

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

Device

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

Device

Using Biodex isokinetic dynanometer and set it in isokinetic mode in 60 degree per second

Isotonic training

Device

Using Biodex isokinetic dynanometer and set it in isotonic mode at 60% of the maximal peak torque

Primary outcomes

  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

  5. Timed up and go test

    Time frame: 4 weeks

    Measure the time taken by a patient to stand up from a chair, walk three meters, return, and sit back on the chair

  6. SF-36

    Time frame: 4 weeks

    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.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2019
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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