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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Oxygen Deficiency
• Intervention / Treatment: Behavioral: 2-month home moderate-intensity exercise

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • University at Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
normalized ∆SmO2 rate	a parameter of muscular oxygenation to indicate the match or mismatch between oxygen supply and oxygen demand during the physical stimulus.	measure twice, at baseline and after 2 months
recovery time	a parameter of muscular oxygenation, time taken in seconds after the exercise to back to the beginning oxygenation level.	measure twice, at baseline and after 2 months
Resting SmO2	a parameter of muscular oxygenation, the average oxygenation level in % while sitting still for 3 minutes before doing physical performance tests.	measure twice, at baseline and after 2 months
Oxyhemoglobin differences	a parameter of cerebral oxygenation, the difference of the oxyhemoglobin in mL per gram before and after the cognitive tests.	measure twice, at baseline and after 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	measure twice, at baseline and after 2 months
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.	measure twice, at baseline and after 2 months
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.	measure twice, at baseline and after 2 months
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.	measure twice, at baseline and after 2 months
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.	measure twice, at baseline and after 2 months
Mini-cog test	An assessment of cognitive performance. A Short term memory test.	measure twice, at baseline and after 2 months
Trail Making Test	An assessment of cognitive performance. A executive function test.	measure twice, at baseline and after 2 months
blood glucose level in mg/dL	Blood glucose level before and after exercise	measure twice, at baseline and after 2 months

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Fei Zhao, University at Buffalo

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2020
• Primary Completion (ACTUAL): June 27, 2021
• Study Completion (ACTUAL): June 27, 2021

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (ACTUAL): November 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms, Respiratory; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoxia
• Other Study ID Numbers: STUDY00004297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No