Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Mental health represents a fundamental dimension of overall well-being, exerting a significant influence on mortality rates, health-related quality of life (HRQoL), levels of disability, and the strain on healthcare systems. As the interest in mental wellness continues to grow, exercise training (ET) has become increasingly recognized as a validated and effective intervention for individuals experiencing mental health challenges. An expanding body of research underscores the adverse effects of physical inactivity, reinforcing the role of exercise as a viable therapeutic strategy.
Well-structured ET interventions have consistently demonstrated benefits across multiple domains, including improvements in physical health, reductions in cardiovascular risk, and enhancements in psychological constructs such as depression, self-esteem, resilience, and self-efficacy. However, the majority of prior studies have been limited to relatively short durations-typically ranging from 4 to 24 weeks, with an average of about 12 weeks. A significant gap in the literature persists regarding the long-term implementation and effectiveness of ET programs, particularly in populations with severe mental illness. Additionally, the small sample sizes commonly seen in previous studies restrict the statistical robustness and generalizability of their outcomes.
The aim of the randomized control trial is to examine whether an 1-year mixed type exercise training program within the hospital setting will improve functional capacity and health-related quality of life. Forty- eight participants will be randomly allocated into two groups: Group A (Exercise group) will receive 3 exercise sessions per week for 1-year and Group B (Control Group) will continue their usual care, without participating in organized exercise programs. Prior to the group random allocation, part of the assessment at the baseline and 1 year follow-up will include lower extremity strength test, muscle power using a dynamometer, aerobic capacity test, balance test, body positioning and health- related quality of life.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A: EXERCISE GROUP | Experimental | Exercise group: 1-year mixed-type exercise training program |
|
| GROUP B: CONTROL GROUP | No Intervention | Control Group: 1-year normal physical activity, without participating in organized sports programs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise intervention | Other | Patients that will be randomly assigned in the group A will be invited to attent 1-year exercise sessions, with frequency 3 sessions per week. The program included 30 minutes of Pilates exercises, strengthening, balance and flexibility exercises, which are performed with rubber bands, mobility sticks and balls. |
| Measure | Description | Time Frame |
|---|---|---|
| Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg Dynamometer | The isometric strength of the lower extremities is evaluated in a semi-squat position using a Baseline Leg Dynamometer, with musclular strength quantified in kilograms (kg). | Baseline |
| Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg Dynamometer | The isometric strength of the lower extremities is evaluated in a semi-squat position using a Baseline Leg Dynamometer, with muscular strength quantified in kilograms (kg). | Follow-up assessment, 12 months post- baseline |
| Handgrip Strength | Evaluation of the isometric handgrip strength using a hand dynamometer | Baseline |
| Handgrip Strength | Evaluation of the isometric handgrip strength using a hand dynamometer | Follow-up assessment, 12 months post- baseline |
| Sit-and-Reach Test | Evaluation of flexibility using sit- and- reach test | Baseline |
| Sit-and-Reach Test | Evaluation of flexibility using sit- and- reach test | Follow-up assessment, 12 months post- baseline |
| 30 -second Sit-to-stand test (STS) | Evaluation of functional capacity and mobility using 30-second STS | Baseline |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evangelia Kouidi | Contact | +302310992189 | kouidi@phed.auth.gr | |
| Theochari Victoria | Contact | victoriatheohari@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sports Medicine Laboratory, Aristotle University of Thessaloniki | Recruiting | Thessaloniki | Thermi | Greece |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 30 -second Sit-to-stand test (STS) | Evaluation of functional capacity and mobility using 30-second STS | Follow-up assessment, 12 months post- baseline |
| Six- Minute Walking Test | Estimation of aerobic capacity through six minute walking test | Baseline |
| Six- Minute Walking Test | Estimation of aerobic capacity through six minute walking test | Follow-up assessment, 12 months post- baseline |
| Berg Balance Scale Test | Evaluation of balance using Berg Balance Scale Test | Baseline |
| Berg Balance Scale Test | Evaluation of balance using Berg Balance Scale Test | Follow-up assessment, 12 months post- baseline |
| Short form Quality of Life (SF-36) | Assessment of Quality of Life using SF-36 | Baseline |
| Short form Quality of Life (SF-36) | Assessment of Quality of Life using SF-36 | Follow-up assessment, 12 months post- baseline |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
Not provided
Not provided