Resistance Training on Depression and Quality of Life in Type 1 Diabetic Women

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

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Resistance exercises; Other: Breathing exercises

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 Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saher Elgayar, Ph.D; Phone Number: +201020429911; Email: saherlotfy020@gmail.com
• Study Contact Backup: Name: Mohammed Elhamrawy, Ph.D

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University Hospital
    • Contact: Mohamed Rady Ewis; Phone Number: 01060667072; Email: mohamedrady@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of type 1 diabetes for more than 5 years
2. Unchanged insulin doses for no less than three months
3. Good glycemic control, defined as glycated hemoglobin levels below 7%
4. Minimal to moderate depressive symptoms
5. Sleep quality impairment

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: Breathing exercises; 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.
Active Comparator: Resistance training group	Other: Resistance exercises; 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.; Other: Breathing exercises; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Depression will be assessed using the Beck Depression Inventory-II	Baseline and 12 weeks later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index	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	At baseline and after 12 weeks

Collaborators and Investigators

• Sponsor: Middle East University
• Investigators: Study Director: Mohamed Saif, National institute for Gerontology

Study record dates

Study Major Dates

• Study Start (Estimated): March 18, 2026
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): July 28, 2026

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Therapeutics; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Breathing Exercises
• Other Study ID Numbers: Resistance Training

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No