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Effects of Moderate Physical Activity on Glycemic Control in Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Brisk Walk

Strength training

Aerobic Exercises

About this trial

This is an interventional other trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants falling in this category would be recruited into the study.
Male/female
Diabetic type 2 patients
Age: 30-70 years
BMI >25
Overweight
Fat % in male> 25
Fat % in female >35
HbA1c level more than 48mmol/mol or >6.5%
Fasting Plasma Glucose level >126 mg/dl (7.0 mmol/l)
Random Plasma glucose level >200 mg/dl (11.1 mmol/l)
Physically active ( have no mobility problems)

Exclusion Criteria:

Participant failing to fall in this category would be excluded of the study.
Type 1 diabetes
Insulin dependant type 2 diabetes
Gestational Diabetes
Hypertension
Cigarette smoking
Cardiovascular Disease
Cerebrovascular disease
Cardiopulmonary Disorders
Cognition Problems
Peripheral Artery Disease
Dyslipidemia
Proliferative or preproliferative retinopathy
Nephropathy
Neuropathy

Sites / Locations

Riphah Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Brisk walk

Aerobic Training

Strength Training

Arm Description

Outcomes

Primary Outcome Measures

HbA1c Levels

Reduction in HbA1c levels

Secondary Outcome Measures

Full Information

NCT ID

NCT04924777

First Posted

June 11, 2021

Last Updated

November 24, 2021

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT04924777

Brief Title

Effects of Moderate Physical Activity on Glycemic Control in Type 2 Diabetes Mellitus

Official Title

Effects of Moderate Physical Activity on Glycemic Control in Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

July 31, 2021 (Actual)

Study Completion Date

July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study design is to determine the effectiveness of moderate physical activity on g;lycemic control in type 2 diabetes mellitus.

Detailed Description

To the best of authors knowledge so far the studies have been conducted on different modes of moderate physical activity on glycemic control in type 2 diabetes, current study goal is to evaluate which mode of moderate physical activity has more significant result on glycemic control in type 2 diabetes and is sustainable in Pakistani society according to the socioeconomic status and cost effectiveness of the modes of moderate physical activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brisk walk

Arm Type

Experimental

Arm Title

Aerobic Training

Arm Type

Experimental

Arm Title

Strength Training

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Brisk Walk

Intervention Description

1-Brisk walk for 30 minutes 2-5 days a week 3-3months

Intervention Type

Other

Intervention Name(s)

Strength training

Intervention Description

1-Strength Training Exercises for 30 minutes. 2-5 days a week 3-3 months

Intervention Type

Other

Intervention Name(s)

Aerobic Exercises

Intervention Description

1-Aerobic exercises for 30 minutes 2-5 Days a week 3-3months

Primary Outcome Measure Information:

Title

HbA1c Levels

Description

Reduction in HbA1c levels

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants falling in this category would be recruited into the study. Male/female Diabetic type 2 patients Age: 30-70 years BMI >25 Overweight Fat % in male> 25 Fat % in female >35 HbA1c level more than 48mmol/mol or >6.5% Fasting Plasma Glucose level >126 mg/dl (7.0 mmol/l) Random Plasma glucose level >200 mg/dl (11.1 mmol/l) Physically active ( have no mobility problems) Exclusion Criteria: Participant failing to fall in this category would be excluded of the study. Type 1 diabetes Insulin dependant type 2 diabetes Gestational Diabetes Hypertension Cigarette smoking Cardiovascular Disease Cerebrovascular disease Cardiopulmonary Disorders Cognition Problems Peripheral Artery Disease Dyslipidemia Proliferative or preproliferative retinopathy Nephropathy Neuropathy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Waqar Ahmad Awan

Organizational Affiliation

Riphah International University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Riphah Rehabilitation Center

City

Islamabad

ZIP/Postal Code

44000

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of Moderate Physical Activity on Glycemic Control in Type 2 Diabetes Mellitus

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