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

NCT ID: NCT04626453

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-29

Study Completion Date

2021-06-27

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Oxygen Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sedentary older adults with Type 2 Diabetes

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

Group Type EXPERIMENTAL

2-month home moderate-intensity exercise

Intervention Type 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.

Active older adults with Type 2 Diabetes

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy older adults

Healthy older adults will not do exercise.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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

* 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.


* 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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Fei Zhao

Ph.D. candidate student, MPT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fei Zhao

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

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University at Buffalo

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004297

Identifier Type: -

Identifier Source: org_study_id

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