Physical Therapy for Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Effect of Moderate Exercise Versus Breaking Sedentary by Light Exercise on Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622371
• Other study ID #: P.T. REC/012/002607
• Status: Completed
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: August 7, 2020

Study information

• Verified date: November 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 7, 2020
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

• Type2 diabetes mellitus.

• Age between 35 and 60.

• BMI=30

Exclusion Criteria:

• Renal failure.

• Cardiopulmonary diseases.

• Lower limb diseases or fracture.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Moderate 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.

Locations

Country	Name	City	State
Egypt	Manal K. youssef	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Weight divided by square of the height	12 week
Primary	Waist to hip ratio	Circumference of the waist at umbalicus/ circumference of gluteal region	12 weeks
Primary	6 minutes walk distance	meters walked in 6 minutes	12 weeks
Primary	Blood glucose	mg/dl	12 weeks
Primary	SF-36	degree	12 weeks