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

Primary Purpose

Diabetes Mellitus, Type 2, Oxygen Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2-month home moderate-intensity exercise
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

sedentary older adults with Type 2 Diabetes

Active older adults with Type 2 Diabetes

Healthy older adults

Arm Description

Sedentary older adults with Type 2 Diabetes as the intervention group will do a 2-month home exercise.

Active older adults with Type 2 Diabetes will not do exercise.

Healthy older adults will not do exercise.

Outcomes

Primary Outcome Measures

normalized ∆SmO2 rate
a parameter of muscular oxygenation to indicate the match or mismatch between oxygen supply and oxygen demand during the physical stimulus.
recovery time
a parameter of muscular oxygenation, time taken in seconds after the exercise to back to the beginning oxygenation level.
Resting SmO2
a parameter of muscular oxygenation, the average oxygenation level in % while sitting still for 3 minutes before doing physical performance tests.
Oxyhemoglobin differences
a parameter of cerebral oxygenation, the difference of the oxyhemoglobin in mL per gram before and after the cognitive tests.

Secondary Outcome Measures

Fatigue
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.
Timed Up and Go test score in seconds
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.
Short Physical Performance Battery
An assessment of physical performance. This test contains three sections: balance, walking speed and chair stand. The scores are 0-12.
Bilateral Heel Raise test
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.
6 Minute Walking Test
An assessment of physical performance. The test assesses time in seconds when participants walk as fast as they can in 6 minutes.
Mini-cog test
An assessment of cognitive performance. A Short term memory test.
Trail Making Test
An assessment of cognitive performance. A executive function test.
blood glucose level in mg/dL
Blood glucose level before and after exercise

Full Information

First Posted
October 30, 2020
Last Updated
September 20, 2021
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT04626453
Brief Title
Oxygenation Changes After 2-month Exercise in Sedentary Older Adults With Diabetes
Official Title
Muscular and Cerebral Oxygenation Changes After Moderate-Intensity Exercise in Sedentary Older Adults With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 29, 2020 (Actual)
Primary Completion Date
June 27, 2021 (Actual)
Study Completion Date
June 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Oxygen Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sedentary older adults with Type 2 Diabetes
Arm Type
Experimental
Arm Description
Sedentary older adults with Type 2 Diabetes as the intervention group will do a 2-month home exercise.
Arm Title
Active older adults with Type 2 Diabetes
Arm Type
No Intervention
Arm Description
Active older adults with Type 2 Diabetes will not do exercise.
Arm Title
Healthy older adults
Arm Type
No Intervention
Arm Description
Healthy older adults will not do exercise.
Intervention Type
Behavioral
Intervention Name(s)
2-month home moderate-intensity exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
normalized ∆SmO2 rate
Description
a parameter of muscular oxygenation to indicate the match or mismatch between oxygen supply and oxygen demand during the physical stimulus.
Time Frame
measure twice, at baseline and after 2 months
Title
recovery time
Description
a parameter of muscular oxygenation, time taken in seconds after the exercise to back to the beginning oxygenation level.
Time Frame
measure twice, at baseline and after 2 months
Title
Resting SmO2
Description
a parameter of muscular oxygenation, the average oxygenation level in % while sitting still for 3 minutes before doing physical performance tests.
Time Frame
measure twice, at baseline and after 2 months
Title
Oxyhemoglobin differences
Description
a parameter of cerebral oxygenation, the difference of the oxyhemoglobin in mL per gram before and after the cognitive tests.
Time Frame
measure twice, at baseline and after 2 months
Secondary Outcome Measure Information:
Title
Fatigue
Description
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.
Time Frame
measure twice, at baseline and after 2 months
Title
Timed Up and Go test score in seconds
Description
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.
Time Frame
measure twice, at baseline and after 2 months
Title
Short Physical Performance Battery
Description
An assessment of physical performance. This test contains three sections: balance, walking speed and chair stand. The scores are 0-12.
Time Frame
measure twice, at baseline and after 2 months
Title
Bilateral Heel Raise test
Description
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.
Time Frame
measure twice, at baseline and after 2 months
Title
6 Minute Walking Test
Description
An assessment of physical performance. The test assesses time in seconds when participants walk as fast as they can in 6 minutes.
Time Frame
measure twice, at baseline and after 2 months
Title
Mini-cog test
Description
An assessment of cognitive performance. A Short term memory test.
Time Frame
measure twice, at baseline and after 2 months
Title
Trail Making Test
Description
An assessment of cognitive performance. A executive function test.
Time Frame
measure twice, at baseline and after 2 months
Title
blood glucose level in mg/dL
Description
Blood glucose level before and after exercise
Time Frame
measure twice, at baseline and after 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Zhao
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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