NCT04622371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

November 4, 2020

Last Update Submit

November 4, 2020

Conditions

Diabetes Mellitus

Keywords

moderate exerciseslight exercisesobesitysedentary behavior

Outcome Measures

Primary Outcomes (5)

  • BMI

    Weight divided by square of the height

    12 week

  • Waist to hip ratio

    Circumference of the waist at umbalicus/ circumference of gluteal region

    12 weeks

  • 6 minutes walk distance

    meters walked in 6 minutes

    12 weeks

  • Blood glucose

    mg/dl

    12 weeks

  • SF-36

    degree

    12 weeks

Study Arms (2)

moderate exercises group

EXPERIMENTAL

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

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.

Other: Moderate exercises

Interventions

Moderate exercisesOTHER

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.

Also known as: Light exercises
Light exercises groupmoderate exercises group

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manal K. youssef

Cairo, 11528, Egypt

Location

MeSH Terms

Conditions

Diabetes MellitusObesitySedentary Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Manal K. Youssef, PhD

    Cairo university, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

January 10, 2020

Primary Completion

June 16, 2020

Study Completion

August 7, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Data can be shared on reasonable request from corresponding author.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
12 weeks
Access Criteria
Data available on reasonable request from corresponding authors.

Locations

EG(1)