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Oxygenation Changes After 2-month Exercise in Sedentary Older Adults With Diabetes

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ClinicalTrials.gov Identifier: NCT04626453
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Fei Zhao, State University of New York at Buffalo

Brief Summary:
The aim of the study is to determine the physiological evidence of how muscular and cerebral oxygenation changes link to fatigue, physical, and cognitive performance after moderate-intensity exercise in sedentary older adults with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Oxygen Deficiency Behavioral: 2-month home moderate-intensity exercise Not Applicable

Detailed Description:
This is an experimental design. One intervention group will do exercise for 2 months and be measured twice, at baseline, and after 2 months. The other 2 control groups will be assessed just once without exercise intervention. Our primary objective is to clarify physiological evidence of how muscular and cerebral oxygenation changes in sedentary older adults with diabetes after low-to-moderate intensity exercise. The secondary objective is to determine fatigue, physical, cognitive performance changes, blood glucose level among sedentary older adults with diabetes after low-to-moderate intensity exercise.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Muscular and Cerebral Oxygenation Changes After Moderate-Intensity Exercise in Sedentary Older Adults With Type 2 Diabetes
Actual Study Start Date : October 29, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sedentary older adults with Type 2 Diabetes
Sedentary older adults with Type 2 Diabetes as the intervention group will do a 2-month home exercise.
Behavioral: 2-month home moderate-intensity exercise
The 2-month exercise will be conducted at the participants' homes. Participants will be recommended to perform the combined exercise, which consists of the resistance exercise and walking at a faster speed than leisure walking at a moderate-intensity, for 6 days/week. They can decide which day they won't perform the exercise. Participants will be encouraged to do progressive resistance exercise and walking twice a day, once in the morning and the other time in the afternoon. Resistance exercise will be suggested to perform every other day for three days/week and walking as the aerobic exercise will be on alternate days for three days/week.

No Intervention: Active older adults with Type 2 Diabetes
Active older adults with Type 2 Diabetes will not do exercise.
No Intervention: Healthy older adults
Healthy older adults will not do exercise.



Primary Outcome Measures :
  1. normalized ∆SmO2 rate [ Time Frame: measure twice, at baseline and after 2 months ]
    a parameter of muscular oxygenation to indicate the match or mismatch between oxygen supply and oxygen demand during the physical stimulus.

  2. recovery time [ Time Frame: measure twice, at baseline and after 2 months ]
    a parameter of muscular oxygenation, time taken in seconds after the exercise to back to the beginning oxygenation level.

  3. Resting SmO2 [ Time Frame: measure twice, at baseline and after 2 months ]
    a parameter of muscular oxygenation, the average oxygenation level in % while sitting still for 3 minutes before doing physical performance tests.

  4. Oxyhemoglobin differences [ Time Frame: measure twice, at baseline and after 2 months ]
    a parameter of cerebral oxygenation, the difference of the oxyhemoglobin in mL per gram before and after the cognitive tests.


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: measure twice, at baseline and after 2 months ]
    Fatigue will be assessed by the Numeric Fatigue Scale (NFS) by selecting a number from 0 to 10. 0 is no fatigued at all, 10 is extremely fatigued.

  2. Timed Up and Go test score in seconds [ Time Frame: measure twice, at baseline and after 2 months ]
    An assessment of physical performance. Time in seconds from sitting up from a chair, walking to 3 meters, turning, walking back to sitting down on a chair.

  3. Short Physical Performance Battery [ Time Frame: measure twice, at baseline and after 2 months ]
    An assessment of physical performance. This test contains three sections: balance, walking speed and chair stand. The scores are 0-12.

  4. Bilateral Heel Raise test [ Time Frame: measure twice, at baseline and after 2 months ]
    An assessment of physical performance. This test askes to do heel raise to the maximum height continuously. Time to fatigued in seconds and the frequencies of heel raise are recorded.

  5. 6 Minute Walking Test [ Time Frame: measure twice, at baseline and after 2 months ]
    An assessment of physical performance. The test assesses time in seconds when participants walk as fast as they can in 6 minutes.

  6. Mini-cog test [ Time Frame: measure twice, at baseline and after 2 months ]
    An assessment of cognitive performance. A Short term memory test.

  7. Trail Making Test [ Time Frame: measure twice, at baseline and after 2 months ]
    An assessment of cognitive performance. A executive function test.

  8. blood glucose level in mg/dL [ Time Frame: measure twice, at baseline and after 2 months ]
    Blood glucose level before and after exercise



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For the intervention group, the inclusion criteria are

    • sedentary older adults 60 years or older who are living in their homes in the community
    • diagnosed type 2 diabetes
    • ambulatory with or without mobility devices such as a cane and/or walker
    • Be able to follow simple exercise instructions without assistance.
  • For the comparison group, the inclusion criteria are

    • individuals aged 60 years or older who are living in their homes, in the community;
    • ambulatory with or without devices;
    • able to follow simple exercise instructions without assistance
    • able to walk six minutes as quickly as possible without any adverse symptoms including extreme pain on feet or joints, dizziness, vertigo, or nausea.

Exclusion Criteria:

  • For the intervention group, the exclusion criteria are

    • foot deformities, cuts, blisters, or amputation, Achilles tendonitis, joint replacements within the past three months, Parkinson's disease, retinopathy such as severe glaucoma, current or uncontrolled vestibular disorders
    • current smoking or smoking within the last 12 months
    • current cardiopulmonary diseases, vascular disease, or stroke
    • dementia indicating the inability to follow exercise instructions independently
    • those who are currently or plan to receive physical therapy in the following three months
    • individuals without English proficiency will be excluded
    • If the individuals with blood glucose level are over 400 mg/dL or HbA1C > 8.0%, and
    • type 1 diabetes.

For the comparison group, the exclusion criteria are

  • individuals who have prediabetes, diabetes, or current cardiopulmonary diseases and stroke
  • current smoking or smoking within the last 12 months
  • individuals with foot deformities, cuts, blisters, or amputation, Achilles tendonitis, joint replacements within the past three months, Parkinson's disease, retinopathy such as severe glaucoma, current or uncontrolled vestibular disorders, and dementia.

Information from the National Library of Medicine

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): NCT04626453


Contacts
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Contact: Fei Zhao 7169072498 fzhao6@buffalo.edu
Contact: Machiko Tomita (716) 829-6740 machikot@buffalo.edu

Locations
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United States, New York
University at Buffalo Recruiting
Buffalo, New York, United States, 14214
Contact: Fei Zhao    716-907-2498    fzhao6@buffalo.edu   
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
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Principal Investigator: Fei Zhao University at Buffalo
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Responsible Party: Fei Zhao, Ph.D. candidate student, MPT, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT04626453    
Other Study ID Numbers: STUDY00004297
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoxia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms, Respiratory