Physical Therapy for Diabetes Mellitus

NCT ID: NCT04622371

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2020-08-07

Brief Summary

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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

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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

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Diabetes Mellitus

Keywords

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moderate exercises light exercises obesity sedentary behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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moderate exercises group

Patients received 30 minutes of aerobic exercise at 40-60% of maximum heart rate

Group Type EXPERIMENTAL

Moderate exercises

Intervention Type OTHER

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.

Light exercises group

Patients treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.

Group Type EXPERIMENTAL

Moderate exercises

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Light exercises

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Renal failure.
* Cardiopulmonary diseases.
* Lower limb diseases or fracture.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Manal k. youssef

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manal K. Youssef, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo university, Egypt

Locations

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Manal K. youssef

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T. REC/012/002607

Identifier Type: -

Identifier Source: org_study_id