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Completed

NCT Number: NCT04626453

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo

Buffalo, New York, 14214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2-month home moderate-intensity exercise

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Fatigue

    Time frame: 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.

  2. Timed Up and Go test score in seconds

    Time frame: 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.

  3. Short Physical Performance Battery

    Time frame: 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.

  4. Bilateral Heel Raise test

    Time frame: 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.

  5. 6 Minute Walking Test

    Time frame: 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.

  6. Mini-cog test

    Time frame: measure twice, at baseline and after 2 months

    An assessment of cognitive performance. A Short term memory test.

  7. Trail Making Test

    Time frame: measure twice, at baseline and after 2 months

    An assessment of cognitive performance. A executive function test.

  8. blood glucose level in mg/dL

    Time frame: measure twice, at baseline and after 2 months

    Blood glucose level before and after exercise

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2020
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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