NCT06245252

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

December 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

February 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

February 7, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

December 19, 2023

Last Update Submit

February 3, 2024

Conditions

Keywords

blood glucoseelectrical stimulationlower extremitiespassive stretchingexercise

Outcome Measures

Primary Outcomes (2)

  • an HbA1c .

    blood glucose levels glycated haemoglobien

    at baseline and after three month

  • 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 Outcomes (2)

  • time of up and go test

    at baseline and after three month

  • score of fatigue severity scale

    at baseline and after three month

Study Arms (2)

group (A)

EXPERIMENTAL

treated by 40-minute passive stretching exercises,three times per week for 12 weeks

Other: passive stretching for group A

group (B)

EXPERIMENTAL

treated by 30 minutes electrical stimulation three times per week for 12 weeks

Other: electrical stimulation for group b

Interventions

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).

Also known as: passive stretching exercises for group A
group (A)

reated by 30 minutes electrical stimulation three times per week for 12 weeks

group (B)

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Badr university

Cairo, Egypt

RECRUITING

Mona Mohamed Abdelkhalek

Cairo, Egypt

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

Muscle Stretching ExercisesElectric Stimulation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPhysical StimulationInvestigative Techniques

Central Study Contacts

Mona Abdelkhalek, assistance professor

CONTACT

Mona Abdelkhalek, assistance professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistance professor

Study Record Dates

First Submitted

December 19, 2023

First Posted

February 7, 2024

Study Start

February 10, 2024

Primary Completion

May 10, 2024

Study Completion

June 10, 2024

Last Updated

February 7, 2024

Record last verified: 2024-01

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