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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04626453
• Other study ID #: STUDY00004297
• Status: Completed
• Phase: N/A
• Start date: October 29, 2020
• Est. completion date: June 27, 2021

Study information

• Verified date: September 2021
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 27, 2021
• Est. primary completion date: June 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypoxia
• Oxygen Deficiency

Intervention

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.

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

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