Influence of practising the Pilates method during pregnancy on the quality of life of pregnant women
| ISRCTN | ISRCTN11298645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11298645 |
| Secondary identifying numbers | IPPECV-2024 |
- Submission date
- 09/06/2024
- Registration date
- 11/06/2024
- Last edited
- 19/06/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Pregnancy is a significant event in a woman's life that can lead to a change in her lifestyle, potentially affecting her quality of life. Pregnancy influences a woman's perceived quality of life, with differences found between pregnant and non-pregnant women, with variations occurring naturally during pregnancy.
In response to these changes, regular moderate physical exercise has positive effects on pregnant women, potentially providing benefits.
Currently, among the types of activities that can be performed during pregnancy, the Pilates method is gaining importance and is recommended as a valid physical activity program during pregnancy. The objective of this method is to achieve muscular harmony through strengthening and flexibility of weaker muscles, practising exercises in a controlled manner guided by a professional. A Pilates program during pregnancy requires adaptation of exercises to the new situation and changes in the body, and participants can start Pilates at any time during pregnancy regardless of whether they have previously trained in the method.
The aim of this study is to determine the influence of practising the Pilates method during pregnancy on the quality of life of pregnant women, evaluate whether it reduces pain in the lower back and pelvis, and determine if it improves the mental health of pregnant women.
Who can participate?
Pregnant women aged over 18 years at 20 weeks of gestation at the beginning of the program
What does the study involve?
Participants will be asked about their attendance or non-attendance to maternal education and Pilates classes held at the Quironsalud Campo de Gibraltar Hospital in Los Barrios, Algeciras (Cádiz). Depending on their response (yes/no), they will be assigned to either the Pilates group or the control group. The intervention/experimental group (which will receive the Pilates method) will attend a physical activity program using the Pilates method, consisting of two sessions per week for eight weeks, with each session lasting 40-45 minutes, at the Quironsalud Campo de Gibraltar Hospital in Los Barrios, Algeciras (Cádiz), supervised by qualified personnel during 4 months. The control group (who will not receive the Pilates method) will not engage in structured physical activity (i.e., at a sports center or under the guidance of a sports professional).
Participants complete a questionnaire twice, once at the beginning and once at the end of the study. An initial evaluation (pretest) will be conducted using a questionnaire for the group that does not practice Pilates and the group that practices Pilates, for comparison of results between both groups. After completing this survey, the Pilates program will commence at the Quironsalud Campo de Gibraltar Hospital in Los Barrios, Cádiz. When the program ends, a final evaluation (post-test) will be conducted in both groups using the same questionnaire for result comparison.
What are the possible benefits and risks of participating?
Participation in this study will not provide any direct benefit, but it is hoped that the information obtained will contribute to expanding scientific knowledge about how Pilates practice during pregnancy can influence quality of life, pain, and mental health, potentially helping other pregnant women in the future. The procedures that will be used during the study are non-invasive and will not involve an increase in the number of prenatal care visits or the tests normally performed during pregnancy. Likewise, no additional visits or tests will be conducted solely for participating in the study. As part of the inconveniences arising from the study, participants will be asked to complete a questionnaire at the beginning and end of the study, as well as sign an informed consent form and practice Pilates.
Where is the study run from?
Hospital Quirónsalud Campo de Gibraltar (Spain)
When is the study starting and how long is it expected to run for?
April 2024 to September 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mr Juan Manuel Mérida Téllez, juanmanuel.merida@alu.uhu.es
Contact information
Public, Scientific, Principal Investigator
Avenida Benajarafe (Conjunto Amatista) Bloque G Planta 3 Puerta 733
Marbella
29604
Spain
 ORCID ID |
0009-0002-2154-0332 |
|---|---|
| Phone | +34 (0)606157765 |
| juanmanuel.merida@alu.uhu.es |
Study information
| Study design | Single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | 45592_PIS.pdf |
| Scientific title | Influence of practising Pilates exercises within a physical activity program developed during pregnancy on perceived quality of life compared to women who have not practised it |
| Study acronym | IPPQL |
| Study hypothesis | Practising the Pilates Method during pregnancy improves the quality of life of pregnant women compared to those who do not practice it. |
| Ethics approval(s) |
Approved 30/05/2024, Research Ethics Committee of Cádiz (Hospital Universitario Puerta del Mar. Despacho 817. 8ª Planta, Cadiz, 11009, Spain; +34 (0)956 002 005; ceic.hpm.sspa@juntadeandalucia.es), ref: SICEIA-2024-000936 |
| Condition | Perceived quality of life among pregnant women |
| Intervention | The study design involves a randomized controlled trial (RCT) where pregnant women will be randomly assigned (using a simple randomization process through the generation of random numbers) to either an experimental group receiving a Pilates-based physical activity program or a control group receiving standard care, with assessments of health outcomes using the SF-36 questionnaire before and after the intervention. A physical activity program using the Pilates method will commence between weeks 26-28 of gestation and conclude between weeks 34-36, lasting 8 weeks, twice a week, with each session lasting 40-45 minutes. The control group will not engage in any structured physical activity program. |
| Intervention type | Other |
| Primary outcome measure | Quality of life measured using the SF-36 health-related quality of life questionnaire at baseline and 8 weeks |
| Secondary outcome measures | 1. Pain assessed using one of the specific domains of the SF-36 questionnaire at baseline and 8 weeks 2. Mental health assessed using one of the specific domains of the SF-36 questionnaire at baseline and 8 weeks |
| Overall study start date | 01/04/2024 |
| Overall study end date | 14/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 140 |
| Participant inclusion criteria | 1. Be over 18 years old 2. Women who have practiced the Pilates Method within a physical activity program during the study period and wish to participate in the study 3. Be at 20 weeks of gestation at the beginning of the program 4. Not suffer from any illness that constitutes a medical contraindication 5. Not have any injury that prevents the performance of physical exercise 6. Not participating in another physical activity program 7. Not having a multiple pregnancy 8. Not taking any medication that may influence the results |
| Participant exclusion criteria | 1. Lack of verbal, reading, and written comprehension of the Spanish language 2. Serious medical complications during pregnancy requiring urgent medical intervention 3. Development of medical conditions contraindicating the continuation of physical exercise, such as preeclampsia or threatened premature labor 4. Severe adverse events related to the practice of Pilates, such as musculoskeletal injuries or falls 5. Significant non-compliance with the exercise program or study protocol follow-up 6. Voluntary withdrawal of informed consent by the participant |
| Recruitment start date | 01/03/2025 |
| Recruitment end date | 30/06/2025 |
Locations
Countries of recruitment
- Spain
Study participating centre
Los Barrios (Cadiz)
11379
Spain
Sponsor information
Hospital/treatment centre
Av. de los Empresarios, Edificio Arttysur S/N
Los Barrioz
11379
Spain
| Phone | +34 (0)956 79 83 00 |
|---|---|
| DPO@quironsalud.es | |
| Website | https://www.quironsalud.com/campo-gibraltar |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Since this study does not have any source of funding, there may not be a formal individual participant data (IPD) sharing plan in place. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 11/06/2024 | No | Yes | ||
| Statistical Analysis Plan | 11/06/2024 | No | No | ||
| Protocol file | 19/06/2024 | No | No |
Additional files
Editorial Notes
19/06/2024: Protocol uploaded.
10/06/2024: Study's existence confirmed by the Research Ethics Committee of Cádiz.
