Passive Stretching Versus Electrical Stimulation on Glucose Level, in Elderly With Type II Diabetes

February 3, 2024 updated by: Mona Mohamed Abdelkhalek

Comparison of Passive Stretching Versus Electrical Stimulation on Glucose Level, Functional Mobility and Perceived-fatigue in Elderly With Type II Diabetes

Sixty elderly diabetics (type II) their age ranged from 60-75 years had been divided into two equal groups; group (A) treated by 40-minute passive stretching exercises, while the group (B) treated by 30 minutes electrical stimulation three times per week for 12 weeks. Blood glucose level,Time up and go test (TUG) and Fatigue severity scale were done before and after 12 weeks of the study.Conclusion: Both electrical stimulation and passive stretching are effective to lowering blood glucose level and can be proposed for those people restricted to perform exercise.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Physical exercise is one of the bases for controlling and treatment type 2 diabetes mellitus. But not all diabetic elderly is able to perform physical exercise because of their physical limitation condition. The approach for those people in this study is electrical stimulation and passive stretching. Purpose: The aim of this study is to compare the effect of passive stretching and electrical stimulation on blood glucose level, functional mobility and Perceived-Fatigue in diabetic elderly. Methods: Sixty elderly diabetics (type II) their age ranged from 60-75 years had been divided into two equal groups; group (A) treated by 40-minute passive stretching exercises, while the group (B) treated by 30 minutes electrical stimulation three times per week for 12 weeks. Blood glucose level,Time up and go test (TUG) and Fatigue severity scale were done before and after 12 weeks of the study.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mona Abdelkhalek, assistance professor
  • Phone Number: 002021024056108
  • Email: 3m.sons@gmail.com

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Badr University
        • Contact:
          • Mona Abdelkhalek, Phd
      • Cairo, Egypt
        • Not yet recruiting
        • Mona Mohamed Abdelkhalek
        • Contact:
        • Contact:
          • mona Abdelkhalek, assistance prof
          • Phone Number: 002021024056108
          • Email: 3m.sons@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • HbA1c value between 6.5% -8.5%,
  • age ranged from 60-75 years patients have
  • body mass index (BMI) from 25 to 29.9 kg/m2,
  • duration of diabetes ranged from 5-7 years. They were
  • on oral hypoglycemic medications at the same dose.
  • All patients were clinically and medically stable when attending the study.

Exclusion Criteria:

  • unstable cardiovascular,
  • chest problems
  • other types of diabetes
  • on insulin therapy
  • chronic renal failure and
  • iron deficient anemia and
  • musculoskeletal disorders which may affect their physical ability to do the exercises.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group (A)
treated by 40-minute passive stretching exercises,three times per week for 12 weeks
Other: passive stretching for group A
A description of stretch is performed 3 times per week for 12 weeks. The stretches included (in the order they were applied): Seated knee flexor (bilateral); Seated knee flexor-hip adductor (bilateral); Seated shoulder lateral flexor (bilateral); Supine hip flexor- knee extensor (unilateral). Seated hip external rotators, extensor (unilateral); Seated shoulder extensors, adductors, retractors (unilateral). Supine knee flexor-plantar flexor (unilateral); Prone hip flexor (unilateral); Seated shoulder flexors, depressors (bilateral); Seated shoulder and elbow flexors (unilateral).
Other Names:
  • passive stretching exercises for group A
Experimental: group (B)
treated by 30 minutes electrical stimulation three times per week for 12 weeks
Other: electrical stimulation for group b
reated by 30 minutes electrical stimulation three times per week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
an HbA1c .
Time Frame: at baseline and after three month
blood glucose levels glycated haemoglobien
at baseline and after three month
fasting blood glucose levels
Time Frame: at baseline and after three month
values were obtained for fasting blood sugar (FBS) levels/baseline, then 2 hours after the meal (postprandial).
at baseline and after three month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of up and go test
Time Frame: at baseline and after three month
measure the time of the test
at baseline and after three month
score of fatigue severity scale
Time Frame: at baseline and after three month
severity from 1 to 7The strongly disagreement was related to number 1 while the strongly agreement was related to number 7. The scoring is completed by calculating the average answer to the questions (adding up all the answers and dividing by nine). Greater FSS scores mean greater perceived-fatigue.
at baseline and after three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mona Mohamed Abdelkhalek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 10, 2024

Primary Completion (Estimated)

May 10, 2024

Study Completion (Estimated)

June 10, 2024

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

February 3, 2024

First Posted (Estimated)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mona 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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