Feasibility Testing an Exercise Program to Improve Cognition for T2DM Patients
Feasibility Testing a Randomized Controlled Trial of an Exercise Program to Improve Cognition for T2DM Patients
1 other identifier
interventional
84
1 country
1
Brief Summary
This proposed study will advance science by providing evidence on the feasibility of a standardized, rigorously designed and delivered exercise program to improve cognition and plasma brain-derived neurotrophic factor (BDNF) levels for individuals with type 2 diabetes. We will also explore how certain genetic variant may influence exercise-induced cognitive improvements and plasma BDNF levels. Findings of the proposed study will establish a comprehensive knowledge base for future research and development of a personalized exercise program for high-risk individuals who are vulnerable to cognitive dysfunction based on their genomic profiles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Jun 2021
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2023
CompletedJanuary 24, 2022
January 1, 2022
2.3 years
October 9, 2020
January 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Episodic memory
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.
Three months
Executive function
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.
Three months
Working memory
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.
Three months
Processing speed
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.
Three months
Secondary Outcomes (6)
Plasma BDNF in ng/mL
Three months
Fasting blood glucose in mg/dL
Three months
HbA1c in percentage
Three months
Weight in kilograms
Three months
Height in meters
Three months
- +1 more secondary outcomes
Study Arms (2)
Aerobic exercise group
EXPERIMENTALAttention control group
PLACEBO COMPARATORInterventions
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.
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
Eligibility Criteria
You may qualify if:
- Participants eligible for this study will be sedentary adults with no major chronic physical or mental disorders but classified as having low physical activity levels determined by the International Physical Activity Questionnaire.
- Participants must have a documented medical diagnosis of T2DM and must be receiving diabetes care at the time of enrollment.
- Participants must be English-speaking and are able to give informed consent.
You may not qualify if:
- include uncontrolled hypertension with resting blood pressure of 160/90 mmHg or higher, having symptoms of coronary ischemia such as chest pain and severe shortness of breath during activities of daily living, loss of consciousness/fainting for any reason, or having any other medical or physical conditions (such as osteoporosis, asthma, spinal cord injury) or symptoms (e.g., pain or swelling in any part of the body) that may interfere with exercise participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas
Fayetteville, Arkansas, 72701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2020
First Posted
October 19, 2020
Study Start
June 1, 2021
Primary Completion
September 24, 2023
Study Completion
September 24, 2023
Last Updated
January 24, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share