Gait, UnsteadyNCT04068285
Neuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus
A study testing Aerobic Exercise in people with Gait, Unsteady and Aerobic Exercise, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on basic gait parameters in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Gait, Unsteady, Aerobic Exercise
- What is being tested?
- Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2019to 1 Jun 2020
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must have type 2 Diabetes mellitus less than 10 years and more than 1 year.
- Participants must have appropriate medical therapy and diet.
- Participants must not be treated with insulin.
- Participants must be exercising less than 210 minutes/ week
Who cannot join
- Participants with prominent cardiovascular disease
- Participants with coronary artery disease
- Participants with moderate to severe valvular disease
- Participants with atrial fibrillation
- Participants with untreated hypertension
- Participants with congenital heart disease
Show all 15Show fewer
- Participants with retinopathy
- Participants with neuropathy
- Participants with macro albuminuria
- Participants with cerebrovascular disease
- Participants with ejection fraction less than 40
- Participants with body mass index greater than 35.
- Participants with prominent ischemic changes in EKG at rest or during exercise.
- Participants with cigarette or alcohol addiction
- Participants on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on basic gait parameters in patients with type 2 diabetes mellitus.
Read the detailed description
Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication that will restrain them from making exercise. 90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1. group will make aerobic exercise which is in the form of high intensity interval exercise 2.group will make aerobic exercise which is in the form of moderate intensity continuous exercise 3. Control group. Exercise groups will be cycling under observation in the hospital setting. Control group will make simple stretching exercises at home. Participants will be requested to complete a 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with basic gait parameters such as cadence, gait speed, stride length, percentages of swing phase and stance phase evaluated by a wireless digital miniature gait analysis system.
- Conditions
- Gait, Unsteady, Aerobic Exercise
- Being tested
- Aerobic Exercise
- Keywords
- Type 2 diabetes mellitus, exercise, aerobic, interval, continuous, gait
- Medical subject headings
- Gait Disorders, Neurologic, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Participants will be making aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval exercise | Active comparator | Participants with type 2 Diabetes mellitus in High intensity interval exercise (HIIE) group will make aerobic exercise using bicycle at high intensity followed by low intensity periods under observation in the hospital.
exercise Receives: Other: Aerobic Exercise |
| Moderate intensity continuous exercise | Active comparator | Participants with type 2 Diabetes mellitus in Moderate intensity continuous exercise (MIC) group will make aerobic exercise using bicycle at moderate intensity during the session under observation in the hospital.
exercise Receives: Other: Aerobic Exercise |
| No Intervention: Control group | No intervention | The participants with type 2 Diabetes mellitus in the control group will make stretching exercise at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed
change in walking speed in m/s
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start4 Nov 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, UnsteadyStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study has 3 arms.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GULIN FINDIKOGLU, Pamukkale University
- Investigators
- Gulin Findikoglu, Assoc Prof, Principal investigator, Pamukkale University,Medical Faculty, PMR Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068285
- Sponsor's protocol ID
- 60116787-0
- Status last verified
- Jun 2020
- First submitted
- 21 Aug 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- 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 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04068285
- Acronym / sponsor ID
- 60116787-0
- Conditions
- Gait, Unsteady, Aerobic Exercise
- Keywords
- Type 2 diabetes mellitus, exercise, aerobic, interval, continuous, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 28 Aug 2019 (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 this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on basic gait parameters in patients with type 2 diabetes mellitus.
Detailed description
Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication that will restrain them from making exercise. 90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1. group will make aerobic exercise which is in the form of high intensity interval exercise 2.group will make aerobic exercise which is in the form of moderate intensity continuous exercise 3. Control group. Exercise groups will be cycling under observation in the hospital setting. Control group will make simple stretching exercises at home. Participants will be requested to complete a 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with basic gait parameters such as cadence, gait speed, stride length, percentages of swing phase and stance phase evaluated by a wireless digital miniature gait analysis system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study has 3 arms.
| Arm | Type | Receives |
|---|---|---|
| High intensity interval exercise | Active comparator | Other: Aerobic ExerciseParticipants with type 2 Diabetes mellitus in High intensity interval exercise (HIIE) group will make aerobic exercise using bicycle at high intensity followed by low intensity periods under observation in the hospital. exercise |
| Moderate intensity continuous exercise | Active comparator | Other: Aerobic ExerciseParticipants with type 2 Diabetes mellitus in Moderate intensity continuous exercise (MIC) group will make aerobic exercise using bicycle at moderate intensity during the session under observation in the hospital. exercise |
| No Intervention: Control group | No intervention | –The participants with type 2 Diabetes mellitus in the control group will make stretching exercise at home |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must have type 2 Diabetes mellitus less than 10 years and more than 1 year.
- Participants must have appropriate medical therapy and diet.
- Participants must not be treated with insulin.
- Participants must be exercising less than 210 minutes/ week
Key exclusion criteria (15 listed)
- Participants with prominent cardiovascular disease
- Participants with coronary artery disease
- Participants with moderate to severe valvular disease
- Participants with atrial fibrillation
- Participants with untreated hypertension
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 |
|---|---|---|
| Aerobic ExerciseParticipants will be making aerobic exercise | Other | High intensity interval exercise, Moderate intensity continuous exercise |
Primary outcome
walking speed
Time frame: 12 weeks
change in walking speed in m/s
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 4 Jun 2020.
- 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.
Gulin Findikoglu, Assoc Prof principal investigator
Pamukkale University,Medical Faculty, PMR Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Gait, Unsteady and Aerobic Exercise, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 4 inclusion and 15 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 4 Jun 2020. 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 Turkey (Türkiye). 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?
walking speed (time frame: 12 weeks). 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 4 Jun 2020; AzTrials last refreshed its copy on 6 Nov 2026.