Clinical trial NCT04622371: Physical Therapy for Diabetes Mellitus
Official title: Effect of Moderate Exercise Versus Breaking Sedentary by Light Exercise on Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: moderate exercises
light exercises
obesity
sedentary behavior
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Type2 diabetes mellitus.
* Age between 35 and 60.
* BMI≥30

Exclusion Criteria:

* Renal failure.
* Cardiopulmonary diseases.
* Lower limb diseases or fracture.

Primary outcomes:
measure: BMI
timeFrame: 12 week
measure: Waist to hip ratio
timeFrame: 12 weeks
measure: 6 minutes walk distance
timeFrame: 12 weeks
measure: Blood glucose
timeFrame: 12 weeks
measure: SF-36
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Manal K. youssef
Study officials:
affiliation: Cairo university, Egypt
name: Manal K. Youssef, PhD
role: PRINCIPAL_INVESTIGATOR
References: