Feasibility Testing an Exercise Program to Improve Cognition for T2DM Patients
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|ClinicalTrials.gov Identifier: NCT04590833|
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Supervised walking on a treadmill Behavioral: Supervised stretching exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Feasibility Testing a Randomized Controlled Trial of an Exercise Program to Improve Cognition for T2DM Patients|
|Estimated Study Start Date :||January 10, 2021|
|Estimated Primary Completion Date :||September 24, 2023|
|Estimated Study Completion Date :||September 24, 2023|
|Experimental: Aerobic exercise group||
Behavioral: Supervised walking on a treadmill
Each participant will be provided with an individualized target heart rate zone based on his/her age. Heart rate during exercise will be measured using a finger pulse oximeter. Following baseline measures, participants will receive instructions on how to use a finger pulse oximeter by a student. For participants who are not physically fit or are just engaging in regular exercise, they will be advised to start walking on a treadmill at a comfortable pace for 5 to 10 minutes at one time.46 Exercise duration and intensity will be progressed from week 3 to week 5, until participants will walk at 40-59% of heart rate reserve based on their age, which will be maintained throughout the study.
|Placebo Comparator: Attention control group||
Behavioral: Supervised stretching exercise
Following baseline measures, a student will demonstrate the use of a pulse oximeter and stretching movements to these participants. Starting on week 3, participants will do the prescribed stretching exercise 3 times a week, maintaining heart rate below 40% of heart rate reserve during exercise. Stretching will target all major muscle-tendon groups including shoulder, chest, neck, truck, lower back, hips, and legs. It will also involve a slow and constant motion that accounts for any physical limitations and physician-specified precautions
- Episodic memory [ Time Frame: Three months ]Picture Sequence Memory Test. Test-retest reliability of the test is 0.77. Convergent validity and discriminant validity is 0.69 and -0.08, respectively.
- Executive function [ Time Frame: Three months ]Dimensional Change Card Sort Test. Test-retest reliability of the test is 0.88. Convergent validity and discriminant validity is -0.51 and 0.14, respectively.
- Working memory [ Time Frame: Three months ]List Sorting Working Memory Test. Test-retest reliability of the test is 0.77. Convergent validity and discriminant validity are 0.58 and 0.30, respectively.
- Processing speed [ Time Frame: Three months ]Pattern Comparison Processing Speed Test. The test takes about 3 minutes to compete. Test-retest reliability of the test is 0.72. Convergent validity and discriminant validity is 0.49 and 0.12, respectively.
- Plasma BDNF in ng/mL [ Time Frame: Three months ]
- Fasting blood glucose in mg/dL [ Time Frame: Three months ]
- HbA1c in percentage [ Time Frame: Three months ]
- Weight in kilograms [ Time Frame: Three months ]
- Height in meters [ Time Frame: Three months ]
- BMI [ Time Frame: Three months ]weight and height will be combined to report BMI in kg/m^2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590833
|Contact: Tingting Liu, PhDfirstname.lastname@example.org|