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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04626453
Enrollment
81
Registered
2020-11-12
Start date
2020-10-29
Completion date
2021-06-27
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Oxygen Deficiency

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.

Interventions

BEHAVIORAL2-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.

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
normalized ∆SmO2 ratemeasure twice, at baseline and after 2 monthsa parameter of muscular oxygenation to indicate the match or mismatch between oxygen supply and oxygen demand during the physical stimulus.
recovery timemeasure twice, at baseline and after 2 monthsa parameter of muscular oxygenation, time taken in seconds after the exercise to back to the beginning oxygenation level.
Resting SmO2measure twice, at baseline and after 2 monthsa parameter of muscular oxygenation, the average oxygenation level in % while sitting still for 3 minutes before doing physical performance tests.
Oxyhemoglobin differencesmeasure twice, at baseline and after 2 monthsa parameter of cerebral oxygenation, the difference of the oxyhemoglobin in mL per gram before and after the cognitive tests.

Secondary

MeasureTime frameDescription
6 Minute Walking Testmeasure twice, at baseline and after 2 monthsAn assessment of physical performance. The test assesses time in seconds when participants walk as fast as they can in 6 minutes.
Mini-cog testmeasure twice, at baseline and after 2 monthsAn assessment of cognitive performance. A Short term memory test.
Fatiguemeasure twice, at baseline and after 2 monthsFatigue 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.
blood glucose level in mg/dLmeasure twice, at baseline and after 2 monthsBlood glucose level before and after exercise
Trail Making Testmeasure twice, at baseline and after 2 monthsAn assessment of cognitive performance. A executive function test.
Timed Up and Go test score in secondsmeasure twice, at baseline and after 2 monthsAn 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.
Short Physical Performance Batterymeasure twice, at baseline and after 2 monthsAn assessment of physical performance. This test contains three sections: balance, walking speed and chair stand. The scores are 0-12.
Bilateral Heel Raise testmeasure twice, at baseline and after 2 monthsAn 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026