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Clinical Trials/NCT04626453
NCT04626453
Completed
Not Applicable

Muscular and Cerebral Oxygenation Changes After Moderate-Intensity Exercise in Sedentary Older Adults With Type 2 Diabetes

State University of New York at Buffalo1 site in 1 country81 target enrollmentOctober 29, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
State University of New York at Buffalo
Enrollment
81
Locations
1
Primary Endpoint
normalized ∆SmO2 rate
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 29, 2020
End Date
June 27, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fei Zhao

Ph.D. candidate student, MPT

State University of New York at Buffalo

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

  • Fatigue(measure twice, at baseline and after 2 months)
  • Mini-cog test(measure twice, at baseline and after 2 months)
  • Trail Making Test(measure twice, at baseline and after 2 months)
  • Timed Up and Go test score in seconds(measure twice, at baseline and after 2 months)
  • Bilateral Heel Raise test(measure twice, at baseline and after 2 months)
  • blood glucose level in mg/dL(measure twice, at baseline and after 2 months)
  • Short Physical Performance Battery(measure twice, at baseline and after 2 months)
  • 6 Minute Walking Test(measure twice, at baseline and after 2 months)

Study Sites (1)

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