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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06245252
Other study ID # Mona 1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 10, 2024
Est. completion date June 10, 2024

Study information

Verified date January 2024
Source Badr University
Contact Mona Abdelkhalek, assistance professor
Phone 002021024056108
Email mona.abdelkhalek@buc.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 10, 2024
Est. primary completion date May 10, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years to 75 Years
Eligibility 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 Design


Intervention

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).
electrical stimulation for group b
reated by 30 minutes electrical stimulation three times per week for 12 weeks

Locations

Country Name City State
Egypt Badr university Cairo
Egypt Mona Mohamed Abdelkhalek Cairo

Sponsors (1)

Lead Sponsor Collaborator
Mona Mohamed Abdelkhalek

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary an HbA1c . blood glucose levels glycated haemoglobien at baseline and after three month
Primary fasting blood glucose levels values were obtained for fasting blood sugar (FBS) levels/baseline, then 2 hours after the meal (postprandial). at baseline and after three month
Secondary time of up and go test measure the time of the test at baseline and after three month
Secondary score of fatigue severity scale 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
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