‘Physio-EndEA’ Study: A Randomized, Parallel-Group Controlled Trial to Evaluate the Effect of a Supervised and Adapted Therapeutic Exercise Program to Improve Quality of Life in Symptomatic Women Diagnosed with Endometriosis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Setting
2.2. Eligibility Criteria
2.3. Intervention
2.3.1. Exercise Intervention Group
2.3.2. Usual Care/Control Group
2.4. Outcome Assessment
2.4.1. Primary Outcome: Health-Related Quality of Life
2.4.2. Secondary Outcomes
- Pain
- 2.
- Muscle thickness
- 3.
- Strength of the lumbopelvic region
- 4.
- Lumbar spine flexibility
- 5.
- Body balance
- 6.
- Functional capacity
- 7.
- Body composition
- 8.
- Fatigue
- 9.
- Quality of sexual life
- 10.
- Gastrointestinal quality of life
- 11.
- Sleep quality
2.5. Recruiting and Participant Timeline
2.6. Sample Size
2.7. Randomization and Blinding
2.8. Data Collection
2.9. Data Analysis
3. Discussion
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Exercise | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | |
---|---|---|---|---|---|---|---|---|---|---|
Part 1 | US-guided training of core stabilization | √ | ||||||||
Biofeedback exercises | √ | |||||||||
Home-based biofeedback exercises | √ | √ | √ | |||||||
Part 2 | Warm-up | 10 min | 10 min | 10 min | 10 min | 10 min | 10 min | 10 min | 10 min | |
Lumbopelvic stabilization exercises 1 | 1 set of 8–10 reps | 1 set of 12 reps | 2 sets of 8 reps | 2 sets of 10 reps | 1 set of 12 reps | 2 sets of 12 reps | 3 sets of 8 reps | 2 sets of 10 reps | ||
Aerobic exercise | 20 min | 20 min | 20 min | 30 min | 35 min | 40 min | 40 min | 40 min | ||
Stretching exercises | 10 min | 10 min | 10 min | 10 min | 10 min | 10 min | 10 min | 10 min | ||
Cool-down 2 | 10 min | 10 min | 10 min | 10 min | 10 min | 10 min | 10 min | 10 min |
Assessment | Instrument 1 | Baseline | Post-Intervention | Detraining |
---|---|---|---|---|
Informed consent | - | √ | ||
Sociodemographic/clinical data | Ad-hoc questionnaire | √ | ||
Body composition | Inelastic tape | √ | √ | √ |
Impedance meter | √ | √ | √ | |
Health-related quality of life | EHP-30 | √ | √ | √ |
Pain | Algometry | √ | √ | √ |
NRS | √ | √ | √ | |
PCS | √ | √ | √ | |
Muscle thickness | Ultrasound imaging | √ | √ | √ |
Muscle strength | Muscle trunk flexor endurance test | √ | √ | √ |
Muscle trunk extensor endurance test | √ | √ | √ | |
Handgrip dynamometry | √ | √ | √ | |
Back strength dynamometry | √ | √ | √ | |
Flexibility | Schöber test | √ | √ | √ |
Body balance | Flamingo test | √ | √ | √ |
Functional capacity | 6MWT | √ | √ | √ |
Fatigue | PFS-R | √ | √ | √ |
Borg Scale | √ | √ | √ | |
Anxiety and depression | HADS | √ | √ | √ |
Quality of sexual life | FSFI | √ | √ | √ |
Gastrointestinal quality of life | GQLI | √ | √ | √ |
Sleep quality | PSQI | √ | √ | √ |
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Salinas-Asensio, M.d.M.; Ocón-Hernández, O.; Mundo-López, A.; Fernández-Lao, C.; Peinado, F.M.; Padilla-Vinuesa, C.; Álvarez-Salvago, F.; Postigo-Martín, P.; Lozano-Lozano, M.; Lara-Ramos, A.; et al. ‘Physio-EndEA’ Study: A Randomized, Parallel-Group Controlled Trial to Evaluate the Effect of a Supervised and Adapted Therapeutic Exercise Program to Improve Quality of Life in Symptomatic Women Diagnosed with Endometriosis. Int. J. Environ. Res. Public Health 2022, 19, 1738. https://doi.org/10.3390/ijerph19031738
Salinas-Asensio MdM, Ocón-Hernández O, Mundo-López A, Fernández-Lao C, Peinado FM, Padilla-Vinuesa C, Álvarez-Salvago F, Postigo-Martín P, Lozano-Lozano M, Lara-Ramos A, et al. ‘Physio-EndEA’ Study: A Randomized, Parallel-Group Controlled Trial to Evaluate the Effect of a Supervised and Adapted Therapeutic Exercise Program to Improve Quality of Life in Symptomatic Women Diagnosed with Endometriosis. International Journal of Environmental Research and Public Health. 2022; 19(3):1738. https://doi.org/10.3390/ijerph19031738
Chicago/Turabian StyleSalinas-Asensio, María del Mar, Olga Ocón-Hernández, Antonio Mundo-López, Carolina Fernández-Lao, Francisco M. Peinado, Carmen Padilla-Vinuesa, Francisco Álvarez-Salvago, Paula Postigo-Martín, Mario Lozano-Lozano, Ana Lara-Ramos, and et al. 2022. "‘Physio-EndEA’ Study: A Randomized, Parallel-Group Controlled Trial to Evaluate the Effect of a Supervised and Adapted Therapeutic Exercise Program to Improve Quality of Life in Symptomatic Women Diagnosed with Endometriosis" International Journal of Environmental Research and Public Health 19, no. 3: 1738. https://doi.org/10.3390/ijerph19031738