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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Oxygen Deficiency
• Interventions: Behavioral: 2-month home moderate-intensity exercise

• Registration Number: NCT04626453
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2020-10-29
• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-12
• Primary Completion: 2021-06-27
• Study Completion: 2021-06-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sedentary older adults with Type 2 Diabetes	2-month home moderate-intensity exercise	Sedentary older adults with Type 2 Diabetes as the intervention group will do a 2-month home exercise.

Primary Outcome Measures

Name	Time	Method
normalized ∆SmO2 rate	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	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	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	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 Outcome Measures

Name	Time	Method
Fatigue	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.
Mini-cog test	measure twice, at baseline and after 2 months	An assessment of cognitive performance. A Short term memory test.
Trail Making Test	measure twice, at baseline and after 2 months	An assessment of cognitive performance. A executive function test.
Timed Up and Go test score in seconds	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.
Bilateral Heel Raise test	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.
Short Physical Performance Battery	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.
blood glucose level in mg/dL	measure twice, at baseline and after 2 months	Blood glucose level before and after exercise
6 Minute Walking Test	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.

Trial Locations

Locations (1)

University at Buffalo; 🇺🇸 Buffalo, New York, United States