Type 1 Diabetes MellitusNCT07466186
Resistance Training on Depression and Quality of Life in Type 1 Diabetic Women
A study testing Resistance exercises and Breathing exercises in people with Type 1 Diabetes Mellitus, run by Middle East University at 1 site in Egypt.
Trial summary
Find out the effects of resistance training on depression, sleep quality, and quality of life in women with type 1 diabetes mellitus Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Resistance exercises and Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Mar 2026to 28 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of type 1 diabetes for more than 5 years
- Unchanged insulin doses for no less than three months
- Good glycemic control, defined as glycated hemoglobin levels below 7%
- Minimal to moderate depressive symptoms
- Sleep quality impairment
Who cannot join
- Presence of other types of diabetes, unstable cardiopulmonary conditions, recent neurological or musculoskeletal problems affecting exercise, pregnancy, postmenopausal status, and the use of sedatives or antidepressants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohammed Elhamrawy, Ph.D contact
Egypt1 site
Tanta University Hospital
Tanta
Mohamed Rady Ewis, 01060667072, mohamedrady@yahoo.com
About this study
Official title: Effect of Resistance Training on Depression and Quality of Life in Type 1 Diabetic Women
Find out the effects of resistance training on depression, sleep quality, and quality of life in women with type 1 diabetes mellitus
Read the detailed description
Seventy-eight women aged 20 to 45 years with type 1 diabetes mellitus will be randomly assigned to either a resistance training group, which will receive both resistance and breathing exercises, or an active control group, which will receive breathing exercises only. The intervention will last for 12 weeks, with resistance exercises will be performed at moderate intensity. Outcomes will be assessed using the Beck Depression Inventory-II, the Pittsburgh Sleep Quality Index, and the Diabetes Quality of Life Questionnaire.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Resistance exercises, Breathing exercises
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercisesOther
The program will include seven exercises targeting major muscle groups: chest press, triceps extension, and shoulder front raise for the upper limbs; back extensions and abdominal crunches for the trunk; and leg press, leg curl, and calf raise for the lower limbs.
Breathing exercisesOther
The procedure will be first demonstrated and explained to each woman prior to the first session. Starting from a crook-lying position, participants will be guided to inhale through the nose for a count of four, hold their breath for another four counts, exhale slowly through the mouth over four counts, and then pause for an additional four counts before repeating the cycle.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training group | Active comparator | Not described Receives: Other: Resistance exercises; Other: Breathing exercises |
| Control group | Active comparator | Not described Receives: Other: Breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Depression will be assessed using the Beck Depression Inventory-II
Measured: Baseline and 12 weeks later
Secondary outcomes (2)
Sleep quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index
Measured: At baseline and 12 weeks later
Quality of life
The Arabic version of the Diabetes Quality of Life Questionnaire will be completed by each participant to assess quality of life
Measured: At baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start18 Mar 2026 (estimated)
- Primary completion21 Jul 2026 (estimated)
- Study completion28 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saher Lotfy El Gayar, Middle East University
- Investigators
- Mohamed Saif, Study director, National institute for Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466186
- Sponsor's protocol ID
- Resistance Training
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistance Training on Depression and Quality of Life in Type 1 Diabetic Women
- ClinicalTrials.gov ID
- NCT07466186
- Acronym / sponsor ID
- Resistance Training
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 18 Mar 2026 (estimated)
- Primary completion
- 21 Jul 2026 (estimated)
- Study completion
- 28 Jul 2026 (estimated)
- First posted
- 12 Mar 2026 (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.
Find out the effects of resistance training on depression, sleep quality, and quality of life in women with type 1 diabetes mellitus
Detailed description
Seventy-eight women aged 20 to 45 years with type 1 diabetes mellitus will be randomly assigned to either a resistance training group, which will receive both resistance and breathing exercises, or an active control group, which will receive breathing exercises only. The intervention will last for 12 weeks, with resistance exercises will be performed at moderate intensity. Outcomes will be assessed using the Beck Depression Inventory-II, the Pittsburgh Sleep Quality Index, and the Diabetes Quality of Life Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training group | Active comparator | Other: Resistance exercises, Other: Breathing exercises |
| Control group | Active comparator | Other: Breathing exercises |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of type 1 diabetes for more than 5 years
- Unchanged insulin doses for no less than three months
- Good glycemic control, defined as glycated hemoglobin levels below 7%
- Minimal to moderate depressive symptoms
- Sleep quality impairment
Key exclusion criteria (1 listed)
- Presence of other types of diabetes, unstable cardiopulmonary conditions, recent neurological or musculoskeletal problems affecting exercise, pregnancy, postmenopausal status, and the use of sedatives or antidepressants.
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 |
|---|---|---|
| Resistance exercisesThe program will include seven exercises targeting major muscle groups: chest press, triceps extension, and shoulder front raise for the upper limbs; back extensions and abdominal crunches for the trunk; and leg press, leg curl, and calf raise for the lower limbs. | Other | Resistance training group |
| Breathing exercisesThe procedure will be first demonstrated and explained to each woman prior to the first session. Starting from a crook-lying position, participants will be guided to inhale through the nose for a count of four, hold their breath for another four counts, exhale slowly through the mouth over four counts, and then pause for an additional four counts before repeating the cycle. | Other | Control group, Resistance training group |
Primary outcome
Depression
Time frame: Baseline and 12 weeks later
Depression will be assessed using the Beck Depression Inventory-II
2 secondary outcomes
Sleep quality
Time frame: At baseline and 12 weeks later
Quality of life
Time frame: At baseline and after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Mohammed Elhamrawy, Ph.D contact
Mohamed Saif study director
National institute for Gerontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercises and Breathing exercises in people with Type 1 Diabetes Mellitus, run by Middle East University at 1 site 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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saher Elgayar, Ph.D (+201020429911, saherlotfy020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Baseline and 12 weeks later). 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 12 Mar 2026.