NCT07466186

Brief Summary

Find out the effects of resistance training on depression, sleep quality, and quality of life in women with type 1 diabetes mellitus

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress50%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

March 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 18, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2026

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 8, 2026

Last Update Submit

March 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Depression

    Depression will be assessed using the Beck Depression Inventory-II

    Baseline and 12 weeks later

Secondary Outcomes (2)

  • Sleep quality

    At baseline and 12 weeks later

  • Quality of life

    At baseline and after 12 weeks

Study Arms (2)

Resistance training group

ACTIVE COMPARATOR
Other: Resistance exercisesOther: Breathing exercises

Control group

ACTIVE COMPARATOR
Other: Breathing exercises

Interventions

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.

Control groupResistance training group

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.

Resistance training group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospital

Tanta, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Mohamed Saif

    National institute for Gerontology

    STUDY DIRECTOR

Central Study Contacts

Saher Elgayar, Ph.D

CONTACT

Mohammed Elhamrawy, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 12, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

July 21, 2026

Study Completion (Estimated)

July 28, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations