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

NCT04626453 | Completed

• 1 other identifier: STUDY00004297
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Oxygen Deficiency

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (8)

• Fatigue

  measure twice, at baseline and after 2 months

• Timed Up and Go test score in seconds

  measure twice, at baseline and after 2 months

• Short Physical Performance Battery

  measure twice, at baseline and after 2 months

• Bilateral Heel Raise test

  measure twice, at baseline and after 2 months

• 6 Minute Walking Test

  measure twice, at baseline and after 2 months

Study Arms (3)

sedentary older adults with Type 2 Diabetes

EXPERIMENTAL

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

Behavioral: 2-month home moderate-intensity exercise

Active older adults with Type 2 Diabetes

NO INTERVENTION

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

Healthy older adults

NO INTERVENTION

Healthy older adults will not do exercise.

Interventions

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.

sedentary older adults with Type 2 Diabetes

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoxia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fei Zhao

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. candidate student, MPT

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 12, 2020
• Study Start: October 29, 2020
• Primary Completion: June 27, 2021
• Study Completion: June 27, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)