Diabetes MellitusNCT04622371
Physical Therapy for Diabetes Mellitus
A study testing Moderate exercises in people with Diabetes Mellitus, run by Cairo University at 1 site in Egypt.
Trial summary
Background: The aim of this study to compare the effect of moderate exercises versus light exercises on patients with type 2 diabetes mellitus. Methods: This 3-month, 2-arm cluster randomized controlled trial involved 60 patients aged between 35and 60 years divided randomly into two groups. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Moderate exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2020to 7 Aug 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type2 diabetes mellitus.
- Age between 35 and 60.
- BMI≥30
Who cannot join
- Renal failure.
- Cardiopulmonary diseases.
- Lower limb diseases or fracture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Moderate Exercise Versus Breaking Sedentary by Light Exercise on Patients With Type 2 Diabetes Mellitus
Background: The aim of this study to compare the effect of moderate exercises versus light exercises on patients with type 2 diabetes mellitus.
Methods: This 3-month, 2-arm cluster randomized controlled trial involved 60 patients aged between 35and 60 years divided randomly into two groups. Group 1 received 30 minutes of aerobic exercise at 40-60% of maximum heart rate. Group 2,Treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.
Read more
Results: At the base line no significant difference were found in both groups in all parameters. After three months of treatment, there is no significant difference in all parameters BMI, p=0.111, waist to hip ratio, p=0.245, 6 minutes' walk, p=0.614, blood glucose, p=0.105 and sf-36, p=0.106. The study approved by ethical committee of faculty of physical therapy, Cairo University REC/012/002607.
Conclusion: Light exercise has the same effect on blood glucose as moderate exercise, so just walking for 5 minutes every 2 hours can be useful for patients with type 2 diabetes mellitus.
Read the detailed description
78 patients have been chosen from department of internal medicine, Cairo university hospitals, Egypt. 8 patients were excluded because 3 have chronic renal failure, 3 have cardiopulmonary diseases and 2 have severe osteoarthritis of knees.
They were divided randomly into two groups, group one will be treated by moderate exercises and group and group 2 will be treated by light exercises.
after division all the procedures were explained to patients.5 patients refused to sign informed consent and excluded from the study.33 patients in group1 and 32 patients in group2.3patients dropped in group1 and excluded from the study and two patients didn't continued the programmed treatment in group 2 and their data removed.
Thirty patients in each group signed an informed consent and complete the treatment program.
- Conditions
- Diabetes Mellitus
- Being tested
- Moderate exercises
- Keywords
- moderate exercises, light exercises, obesity, sedentary behavior
- Medical subject headings
- Diabetes Mellitus, Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate exercisesOther
Also called Light exercises
Group 1 received 30 minutes of aerobic exercise at 40-60% of maximum heart rate. Group 2,Treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.
| Study group | Role | What they receive |
|---|---|---|
| moderate exercises group | Experimental | Patients received 30 minutes of aerobic exercise at 40-60% of maximum heart rate Receives: Other: Moderate exercises |
| Light exercises group | Experimental | Patients treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily. Receives: Other: Moderate exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Weight divided by square of the height
Measured: 12 week
Waist to hip ratio
Circumference of the waist at umbalicus/ circumference of gluteal region
Measured: 12 weeks
6 minutes walk distance
meters walked in 6 minutes
Measured: 12 weeks
Blood glucose
mg/dl
Measured: 12 weeks
SF-36
degree
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 posted10 Nov 2020
- Study start10 Jan 2020
- Primary completion16 Jun 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm cluster randomized controlled trial involved 60 patients aged between 35and 60 years divided randomly into two groups. Group 1 received 30 minutes of aerobic exercise at 40-60% of maximum heart rate. Group 2,Treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal k. youssef, Cairo University
- Investigators
- Manal K. Youssef, PhD, Principal investigator, Cairo university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622371
- Sponsor's protocol ID
- P.T. REC/012/002607
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared on reasonable request from corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moderate Exercise Versus Breaking Sedentary by Light Exercise on Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04622371
- Acronym / sponsor ID
- P.T. REC/012/002607
- Conditions
- Diabetes Mellitus
- Keywords
- moderate exercises, light exercises, obesity, sedentary behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 10 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.
Background: The aim of this study to compare the effect of moderate exercises versus light exercises on patients with type 2 diabetes mellitus.
Methods: This 3-month, 2-arm cluster randomized controlled trial involved 60 patients aged between 35and 60 years divided randomly into two groups. Group 1 received 30 minutes of aerobic exercise at 40-60% of maximum heart rate. Group 2,Treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.
Results: At the base line no significant difference were found in both groups in all parameters. After three months of treatment, there is no significant difference in all parameters BMI, p=0.111, waist to hip ratio, p=0.245, 6 minutes' walk, p=0.614, blood glucose, p=0.105 and sf-36, p=0.106. The study approved by ethical committee of faculty of physical therapy, Cairo University REC/012/002607.
Conclusion: Light exercise has the same effect on blood glucose as moderate exercise, so just walking for 5 minutes every 2 hours can be useful for patients with type 2 diabetes mellitus.
Detailed description
78 patients have been chosen from department of internal medicine, Cairo university hospitals, Egypt. 8 patients were excluded because 3 have chronic renal failure, 3 have cardiopulmonary diseases and 2 have severe osteoarthritis of knees.
They were divided randomly into two groups, group one will be treated by moderate exercises and group and group 2 will be treated by light exercises.
after division all the procedures were explained to patients.5 patients refused to sign informed consent and excluded from the study.33 patients in group1 and 32 patients in group2.3patients dropped in group1 and excluded from the study and two patients didn't continued the programmed treatment in group 2 and their data removed.
Thirty patients in each group signed an informed consent and complete the treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2-arm cluster randomized controlled trial involved 60 patients aged between 35and 60 years divided randomly into two groups. Group 1 received 30 minutes of aerobic exercise at 40-60% of maximum heart rate. Group 2,Treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.
| Arm | Type | Receives |
|---|---|---|
| moderate exercises group | Experimental | Other: Moderate exercisesPatients received 30 minutes of aerobic exercise at 40-60% of maximum heart rate |
| Light exercises group | Experimental | Other: Moderate exercisesPatients treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Type2 diabetes mellitus.
- Age between 35 and 60.
- BMI≥30
Key exclusion criteria (3 listed)
- Renal failure.
- Cardiopulmonary diseases.
- Lower limb diseases or fracture.
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 |
|---|---|---|
| Moderate exercisesAlso: Light exercisesGroup 1 received 30 minutes of aerobic exercise at 40-60% of maximum heart rate. Group 2,Treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily. | Other | Light exercises group, moderate exercises group |
Primary outcome
BMI
Time frame: 12 week
Weight divided by square of the height
Waist to hip ratio
Time frame: 12 weeks
Circumference of the waist at umbalicus/ circumference of gluteal region
6 minutes walk distance
Time frame: 12 weeks
meters walked in 6 minutes
Blood glucose
Time frame: 12 weeks
mg/dl
SF-36
Time frame: 12 weeks
degree
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 10 Nov 2020.
- Individual participant dataSharing planned: Yes. Data can be shared on reasonable request from corresponding author.
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A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
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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.
Manal K. Youssef, PhD principal investigator
Cairo university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate exercises in people with Diabetes Mellitus, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 3 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 10 Nov 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 Egypt. 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?
BMI (time frame: 12 week). The study lists 5 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 10 Nov 2020.