Type II DiabetesNCT06245252
Passive Stretching Versus Electrical Stimulation on Glucose Level, in Elderly With Type II Diabetes
A study testing passive stretching for group A and electrical stimulation for group b in people with Type II Diabetes, run by Mona Mohamed Abdelkhalek at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- passive stretching for group A and electrical stimulation for group b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Feb 2024to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Badr university
Cairo
Mona Abdelkhalek, Phd
- Not yet recruiting
Mona Mohamed Abdelkhalek
Cairo
Mona Abdelkhalek, assistance prof, 002021024056108, mona.abdelkhalek@buc.edu.eg
mona Abdelkhalek, assistance prof, 002021024056108, 3m.sons@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Type II Diabetes
- Being tested
- passive stretching for group A, electrical stimulation for group b
- Keywords
- blood glucose, electrical stimulation, lower extremities, passive stretching, exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive stretching for group AOther
Also called passive stretching exercises 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 bOther
reated by 30 minutes electrical stimulation three times per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| group (A) | Experimental | treated by 40-minute passive stretching exercises,three times per week for 12 weeks Receives: Other: passive stretching for group A |
| group (B) | Experimental | treated by 30 minutes electrical stimulation three times per week for 12 weeks Receives: Other: electrical stimulation for group b |
What is being measured
The primary outcome is the main question the study is designed to answer.
an HbA1c .
blood glucose levels glycated haemoglobien
Measured: 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).
Measured: at baseline and after three month
Secondary outcomes (2)
time of up and go test
measure the time of the test
Measured: at baseline and after three month
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.
Measured: at baseline and after three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start10 Feb 2024 (estimated)
- Primary completion10 May 2024 (estimated)
- Study completion10 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mona Mohamed Abdelkhalek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mona Mohamed Abdelkhalek, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245252
- Sponsor's protocol ID
- Mona 1
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Passive Stretching Versus Electrical Stimulation on Glucose Level, Functional Mobility and Perceived-fatigue in Elderly With Type II Diabetes
- ClinicalTrials.gov ID
- NCT06245252
- Acronym / sponsor ID
- Mona 1
- Conditions
- Type II Diabetes
- Keywords
- blood glucose, electrical stimulation, lower extremities, passive stretching, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mona Mohamed AbdelkhalekUniversity, hospital or other
- Study start
- 10 Feb 2024 (estimated)
- Primary completion
- 10 May 2024 (estimated)
- Study completion
- 10 Jun 2024 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group (A) | Experimental | Other: passive stretching for group Atreated by 40-minute passive stretching exercises,three times per week for 12 weeks |
| group (B) | Experimental | Other: electrical stimulation for group btreated by 30 minutes electrical stimulation three times per week for 12 weeks |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- unstable cardiovascular,
- chest problems
- other types of diabetes
- on insulin therapy
- chronic renal failure and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| passive stretching for group AAlso: passive stretching exercises for group AA 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 | group (A) |
| electrical stimulation for group breated by 30 minutes electrical stimulation three times per week for 12 weeks | Other | group (B) |
Primary outcome
an HbA1c .
Time frame: at baseline and after three month
blood glucose levels glycated haemoglobien
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).
2 secondary outcomes
time of up and go test
Time frame: at baseline and after three month
score of fatigue severity scale
Time frame: at baseline and after three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing passive stretching for group A and electrical stimulation for group b in people with Type II Diabetes, run by Mona Mohamed Abdelkhalek at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona Abdelkhalek, assistance professor (002021024056108, mona.abdelkhalek@buc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
an HbA1c . (time frame: at baseline and after three month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.