Physical therapy to improve quality of life in major depression
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
This program will try twice-weekly physical therapy sessions with exercises and health education to see if adults admitted for major depressive disorder in a short-stay psychiatric unit have better quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad San Jorge Academic / other |
| Locations | 1 site (Zaragoza, Aragon) |
| Trial ID | NCT06983405 on ClinicalTrials.gov |
What this trial studies
This pilot uses a concurrent nested mixed-methods design with a quantitative pre–post component and qualitative focus groups to test a physical therapy program embedded in inpatient care for Major Depressive Disorder. Trained physical therapists will deliver twice-weekly 45-minute sessions including active joint mobility, progressive strength training with body weight or elastic bands, balance exercises, and progressive muscle relaxation, together with brief health education on the benefits of physical activity and adherence strategies. The program is tailored to each patient's functional capacity and length of stay (anticipated 3–6 weeks), and outcome measures will be collected before and after the intervention. Focus groups will gather participant experiences and perceived barriers to continuing activity after discharge.
Who should consider this trial
Good fit: Adults (18+) admitted to the short-stay psychiatry unit at Hospital Royo Villanova in Zaragoza with a physician-confirmed diagnosis of Major Depressive Disorder who can safely participate in twice-weekly sessions and provide informed consent.
Not a fit: Patients with severe comorbid physical or cognitive conditions that prevent safe participation, those requiring continuous nursing supervision, or those unable to follow instructions are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could improve quality of life, physical function, and mood and help patients adopt longer-term physical activity habits.
How similar studies have performed: Exercise interventions have shown benefits for depressive symptoms in outpatient and community settings, but a tailored inpatient physical therapy program with integrated health education is relatively novel and supported mainly by limited pilot data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion and Exclusion Criteria for Patients with Major Depressive Disorder (MDD): Inclusion Criteria: * 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. Exclusion Criteria: * Presence of a comorbid physical or mental illness whose clinical characteristics and/or severity impede comprehension and/or adherence to the physical therapy interventions. * Presence of a physical or mental dysfunction or disability that constitutes a total or partial contraindication for physical therapy techniques. * Legal incapacity or pregnancy. * Present a significant risk of self-harm or suicide requiring clinical management that takes precedence over study participation (this exclusion will be determined by the responsible medical team). Inclusion and Exclusion Criteria for Healthcare Professionals at Royo Villanova Hospital: Inclusion Criteria: * 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. Exclusion Criteria: * Professionals from the unit who were not actively employed under a single, permanent, or temporary employment contract throughout the entire duration of the physical therapy intervention implementation period. * Be on sick leave or parental leave during the period of qualitative data collection. * Have been transferred to another unit or healthcare center prior to the commencement of qualitative data collection.
Where this trial is running
Zaragoza, Aragon
- Hospital Royo Villanova — Zaragoza, Aragon, Spain (Recruiting)
Study contacts
- Principal investigator: José Lesmes Poveda López — Universidad San Jorge
- Study coordinator: Carolina Jiménez Sánchez, Dr
- Email: cjimenez@usj.es
- Phone: +0034649612644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.