Diabetes Mellitus, Type 2NCT04626453
Oxygenation Changes After 2-month Exercise in Sedentary Older Adults With Diabetes
A study testing 2-month home moderate-intensity exercise in people with Diabetes Mellitus, Type 2 and Oxygen Deficiency, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Oxygen Deficiency
- What is being tested?
- 2-month home moderate-intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2020to 27 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muscular and Cerebral Oxygenation Changes After Moderate-Intensity Exercise in Sedentary Older Adults With Type 2 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Oxygen Deficiency
- Being tested
- 2-month home moderate-intensity exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-month home moderate-intensity exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
normalized ∆SmO2 rate
a parameter of muscular oxygenation to indicate the match or mismatch between oxygen supply and oxygen demand during the physical stimulus.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: measure twice, at baseline and after 2 months
Secondary outcomes (8)
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.
Measured: measure twice, at baseline and after 2 months
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.
Measured: measure twice, at baseline and after 2 months
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.
Measured: measure twice, at baseline and after 2 months
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.
Measured: measure twice, at baseline and after 2 months
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.
Measured: measure twice, at baseline and after 2 months
Mini-cog test
An assessment of cognitive performance. A Short term memory test.
Measured: measure twice, at baseline and after 2 months
Trail Making Test
An assessment of cognitive performance. A executive function test.
Measured: measure twice, at baseline and after 2 months
blood glucose level in mg/dL
Blood glucose level before and after exercise
Measured: measure twice, at baseline and after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start29 Oct 2020
- Primary completion27 Jun 2021
- Study completion27 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Zhao, State University of New York at Buffalo
- Investigators
- Fei Zhao, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626453
- Sponsor's protocol ID
- STUDY00004297
- Status last verified
- Sep 2021
- First submitted
- 30 Oct 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscular and Cerebral Oxygenation Changes After Moderate-Intensity Exercise in Sedentary Older Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04626453
- Acronym / sponsor ID
- STUDY00004297
- Conditions
- Diabetes Mellitus, Type 2, Oxygen Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 27 Jun 2021 (actual)
- Study completion
- 27 Jun 2021 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sedentary older adults with Type 2 Diabetes | Experimental | Behavioral: 2-month home moderate-intensity exerciseSedentary older adults with Type 2 Diabetes as the intervention group will do a 2-month home 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For the intervention group, the inclusion criteria are
- For the comparison group, the inclusion criteria are
Key exclusion criteria (13 listed)
- For the intervention group, the exclusion criteria are
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-month home moderate-intensity exerciseThe 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. | Behavioural | sedentary older adults with Type 2 Diabetes |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
Fatigue
Time frame: measure twice, at baseline and after 2 months
Timed Up and Go test score in seconds
Time frame: measure twice, at baseline and after 2 months
Short Physical Performance Battery
Time frame: measure twice, at baseline and after 2 months
Bilateral Heel Raise test
Time frame: measure twice, at baseline and after 2 months
6 Minute Walking Test
Time frame: measure twice, at baseline and after 2 months
Mini-cog test
Time frame: measure twice, at baseline and after 2 months
Trail Making Test
Time frame: measure twice, at baseline and after 2 months
blood glucose level in mg/dL
Time frame: measure twice, at baseline and after 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Zhao principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-month home moderate-intensity exercise in people with Diabetes Mellitus, Type 2 and Oxygen Deficiency, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
normalized ∆SmO2 rate (time frame: measure twice, at baseline and after 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.