Physical Therapy for Diabetes Mellitus
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.
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11528
- Manal K. youssef
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type2 diabetes mellitus.
- Age between 35 and 60.
- BMI≥30
Exclusion Criteria:
- Renal failure.
- Cardiopulmonary diseases.
- Lower limb diseases or fracture.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: moderate exercises group
Patients received 30 minutes of aerobic exercise at 40-60% of maximum heart rate
|
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.
Other Names:
|
|
Experimental: Light exercises group
Patients treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI
Time Frame: 12 week
|
Weight divided by square of the height
|
12 week
|
|
Waist to hip ratio
Time Frame: 12 weeks
|
Circumference of the waist at umbalicus/ circumference of gluteal region
|
12 weeks
|
|
6 minutes walk distance
Time Frame: 12 weeks
|
meters walked in 6 minutes
|
12 weeks
|
|
Blood glucose
Time Frame: 12 weeks
|
mg/dl
|
12 weeks
|
|
SF-36
Time Frame: 12 weeks
|
degree
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manal K. Youssef, PhD, Cairo University, Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T. REC/012/002607
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.