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Effectiveness of a Physical Therapy Program Based on Therapeutic Physical Exercise and Health Education to Improve Quality of Life and Health Status in Major Depressive Disorder: A Mixed-Method Pilot Study Protocol

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Major Depressive Disorder (MDD) significantly impacts quality of life and health status. Standard treatments include medical, psychological, and pharmacological approaches, with physical therapy often playing a less central role. This pilot study aims to investigate the potential benefits of incorporating a physical therapy program, based on therapeutic exercise and health education, within the management of MDD in a short-stay psychiatric unit. This project will implement a physical therapy intervention consisting of twice-weekly sessions of active joint mobility exercises, strength training (body weight/elastic bands), balance exercises, and progressive muscle relaxation, integrated with health education on the benefits of physical activity for mental health and strategies for long-term adherence. Adult patients (over 18 years) diagnosed with MDD, admitted to the short-stay psychiatry unit of Royo Villanova Hospital in Zaragoza and under regular medical, psychological, and pharmacological treatment, will be recruited for this study. All participants will receive the physical therapy program in addition to their standard care. The main objective is to analyze the preliminary efficacy of a physical therapy intervention program based on health education and therapeutic exercise in improving quality of life and health status in adults with MDD during their stay in a short-stay psychiatric unit. A secondary objective is to explore the perceptions of these patients and the healthcare professionals regarding the implementation of this multimodal treatment approach, including barriers and facilitators encountered. Hypothesis: A physical therapy program integrating therapeutic exercise and health education is feasible and preliminarily effective in improving quality of life and health status in adults with MDD in a short-stay psychiatric unit and is perceived positively by both patients and healthcare professionals regarding its implementation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Be 18 years of age or older.

• Be currently admitted to the short-stay inpatient unit of the Psychiatry Department at Royo Villanova Hospital (Zaragoza).

• Have a physician-confirmed diagnosis of Major Depressive Disorder (MDD) according to current diagnostic criteria (ICD-10 or DSM-5).

• Be receiving regular medical, psychological, and/or pharmacological treatment for their MDD.

• Not require continuous supervision and control by nursing staff during data collection and the intervention.

• Have provided written informed consent to participate in the study.

• Be a healthcare professional (physician, nurse, physical therapist, occupational therapist, etc.) or non-healthcare staff member (nursing assistant, orderly, etc.) within the short-stay inpatient Psychiatry Department at Royo Villanova Hospital (Zaragoza).

• Be actively employed under a single, permanent, or temporary employment contract throughout the duration of the physical therapy intervention implementation period.

• Have provided written informed consent to participate in the study.

Locations
Other Locations
Spain
Hospital Royo Villanova
RECRUITING
Zaragoza
Contact Information
Primary
Carolina Jiménez Sánchez, Dr
cjimenez@usj.es
+0034649612644
Backup
José Lesmes Poveda López
jlpoveda@usj.es
+0034669946333
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 50
Treatments
Experimental: Physical Therapy Intervention Group
Participants in this arm will receive a physical therapy program consisting of twice-weekly, 45-minute sessions of active joint mobility exercises, strength exercises (body weight/elastic bands), balance exercises, and progressive muscle relaxation, integrated with health education on the relationship between physical activity and mental health, benefits of exercise, strategies for increasing physical activity, self-assessment techniques, and community resources. This intervention will be delivered in addition to their standard medical, psychological, and pharmacological treatment for Major Depressive Disorder.
Related Therapeutic Areas
Sponsors
Leads: Universidad San Jorge

This content was sourced from clinicaltrials.gov