Clinical trial NCT04626453: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Oxygen Deficiency
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 81
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: normalized ∆SmO2 rate
timeFrame: measure twice, at baseline and after 2 months
measure: recovery time
timeFrame: measure twice, at baseline and after 2 months
measure: Resting SmO2
timeFrame: measure twice, at baseline and after 2 months
measure: Oxyhemoglobin differences
timeFrame: measure twice, at baseline and after 2 months
Secondary outcomes:
measure: Fatigue
timeFrame: measure twice, at baseline and after 2 months
measure: Timed Up and Go test score in seconds
timeFrame: measure twice, at baseline and after 2 months
measure: Short Physical Performance Battery
timeFrame: measure twice, at baseline and after 2 months
measure: Bilateral Heel Raise test
timeFrame: measure twice, at baseline and after 2 months
measure: 6 Minute Walking Test
timeFrame: measure twice, at baseline and after 2 months
measure: Mini-cog test
timeFrame: measure twice, at baseline and after 2 months
measure: Trail Making Test
timeFrame: measure twice, at baseline and after 2 months
measure: blood glucose level in mg/dL
timeFrame: measure twice, at baseline and after 2 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Fei Zhao
role: PRINCIPAL_INVESTIGATOR
References: