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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Quality of Life
研究概览
简要总结
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.
详细描述
This project employs a concurrent nested mixed-methods pilot study with quantitative dominance to evaluate a physical therapy intervention program for adults with Major Depressive Disorder (MDD) within a short-stay psychiatric unit. The quantitative component utilizes a quasi-experimental pre-post design, while the qualitative aspect employs a narrative design through focus groups.
Intervention Protocol:
The physical therapy intervention will be delivered by trained physical therapists in twice-weekly, 45-minute sessions tailored to the participant's length of hospital stay (anticipated 3-6 weeks). Each session will systematically incorporate:
Active Joint Mobility: A series of gentle, controlled movements targeting major joints to maintain or improve their range of motion.
Progressive Strength Training: Low-to-moderate intensity exercises utilizing the participant's own body weight and progressive resistance elastic bands, focusing on key muscle groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion and
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Physical Therapy Program for MDD (Other)
结局指标
主要结局
Change in Quality of Life
时间窗: From enrollment to the end of treatment at 3-6 weeks
Change in the score on the European quality of life questionnaire or EuroQol 5-Dimension 3-Level Spanish version questionnaire (EQ-5D-3L). The EQ-5D-3L health questionnaire is a questionnaire that can be self-administered or conducted through an interview, which allows for assessing the health status in relation to various patient dimensions (mobility, pain, mental health, etc.). It consists of 5 questions with 3 response options (good health = 1, some problems = 2, or health problem = 3), where the responses are coded and coefficients are applied according to the responses to obtain a reference value; and on the other hand, it consists of a 20-centimeter vertical visual analogue scale, with values from 0 = worst health state to 100 = best health state, where the patient indicates the current perceived health value. It is a validated tool widely used in health and research.
次要结局
- Change in Severity of Depressive Symptoms(From enrollment to the end of treatment at 3-6 weeks)
- Change in Pain Intensity(From enrollment to the end of treatment at 3-6 weeks)
- Change in General Self-Efficacy(From enrollment to the end of treatment at 3-6 weeks)
- Healthcare Satisfaction Level(Up to 6 weeks post-baseline - measured only at this time point)