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

University at Buffalo (UB)

Status: Completed

Conditions: Oxygen Deficiency; Diabetes Mellitus, Type 2

Treatments: Behavioral: 2-month home moderate-intensity exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04626453

STUDY00004297

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 3 patient groups

sedentary older adults with Type 2 Diabetes

Experimental group

Description:

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

Treatment:

Behavioral: 2-month home moderate-intensity exercise

Active older adults with Type 2 Diabetes

No Intervention group

Description:

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

Healthy older adults

No Intervention group

Description:

Healthy older adults will not do exercise.