Clinical trial: NCT05493319
Section: Confidentiality
Subsections: 5. Confidentiality|8. Storage And Protection Of Information

The confidentiality of your identity will be protected by the following measures: 1. Only the principal investigator and her team will have access to the data collected during the evaluations. 2. The interview and answers to the questionnaires will receive a code for each participant, which will only be known by the researcher responsible for this study and will be carried out in a favorable environment that stimulates communication and the anonymity chosen by the participant. 3. All members of the research team agree to protect the confidentiality of the data, by signing a confidentiality letter. 4. The Google Meet, Teams and WhatsApp platforms have adequate security and privacy when it is the host who creates the meetings and/or makes the video calls. In the general analysis of the data, a code structure will be used to identify the information that arises, its belonging to the instrument and the moment in which it was carried out. Given the characteristics of the study, the data will only be used in academic research instances and those specific to research dissemination.  
In the presentation of results, any possible indication that allows a possible identification such as places, institutions, etc. will be reserved. Likewise, the Responsible Investigator assumes a confidentiality commitment to protect the identity of all those involved in this study. It is important to consider that the evaluations and intervention will not be recorded.

All the information collected from this investigation will always be protected and in the care of the Responsible Investigator, who will allocate a locked locker in her office where all documents of this investigation will be kept. It is important to consider that only in the event that the interview is conducted directly to your telephone number will your authorization to participate in the study be recorded, the interview and data collection will not be recorded. The interview and application of the questionnaires will only be carried out by the Researcher responsible for recruiting the participants, who will send the data to the Researcher Responsible for the study. All electronic material will be duly stored and backed up in personal computer equipment with the researcher's password. In addition, the research team undertakes to maintain the protection of the information collected during and after the end of the study. Both this consent and the printed documents that are generated and necessary to use will be stored for five years from the end of the study, once the term has ended, they will be removed in a reserved manner.
Clinical trial: NCT05493319
Section: Participant Responsibilities
Subsections: 4. Your Participation In The Study|10. Commitment

Your participation in this study is free and voluntary, and you may request to be excluded from this research and that your interventions not be considered in this research without prior justification or prejudice to you. If you participate in this research, you do so with your express informed consent, which you sign and authorize. In addition, you have the right to withdraw from the activity at any time, without explanation. Once the activity is finished and the data has been collected, you have the right to access the results obtained in the activity.

By accepting the participants agree to: 1. Provide real information in each instance that is requested and respond according to their conceptions, knowledge and experiences, as well as to use a habitual language when responding.
Clinical trial: NCT05493319
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 6. Benefits|7. Risks Or Inconveniences Associated With Participation

This study presents a direct benefit to you. In this sense, after completing the interview and answering the questionnaires, you will receive 4 weeks of standardized kinesthetic intervention, with specific exercises for managing the side effects of gynecological cancer treatment. As a result of your participation, no economic incentives of any kind will be generated. It should be noted that your participation in this study only has eventual data network costs associated with you to participate in the remote evaluation and intervention, via an online platform.

If any discomfort is generated as a result of any question or reflection during your participation in the interview and answers to the questionnaires, the responsible Kinesiologist collaborator will try to emotionally contain and provide the required assistance. During the first training sessions, you may feel discomfort in the muscles as a result of the exercises performed, but it is transitory and does not usually last more than 48 hours. The intensity of the exercises is maintained according to your tolerance and without generating pain. If the discomfort persists, the exercise will be performed at a lower intensity or interrupted.
Clinical trial: NCT05493319
Section: Procedures
Subsections: 3. Metodology

The present study consists of 3 evaluations and an intervention with training: the first two will be carried out before starting the intervention, with an interval of one week each; the third evaluation will be carried out after 4 weeks of intervention. The evaluations will be carried out by two collaborating researchers, a Kinesiologist Master in Kinesiology (Lily Berríos Contreras) and an undergraduate student in Kinesiology (Francisca Valdivia) and will last approximately 40 minutes. An online platform will be used according to your preference to carry out all the measurements that will be the following: a) Personal data related to age and history of gynecological cancer, such as date of diagnosis and previous treatments performed. b) Evaluation of fatigue, symptoms of urinary incontinence, sexual function and quality of life, through specific questionnaires for patients treated for cancer (you will be asked to answer the questionnaires).  
c) Recording of your perception of effort to exercise, using a scale, evaluation of the rhythm of your breathing, by counting your chest movements during breathing and heartbeat, with your help by counting the pulsation of your carotid artery, located in the neck.  
The training will be carried out remotely, being supervised twice a week and once unsupervised, following a pattern of exercises at home, for 4 weeks. The intervention will be carried out by the main researcher (Ivana Leao Ribeiro), the students Valeria Roteli and Camila Rojas. You will be randomly assigned to the conventional or unconventional intervention group. The conventional intervention consists of aerobic and muscle strength exercises (3 sets of 8-12 repetitions of 8 exercises), using only body weight. The intervention will last 50 minutes each session. The unconventional intervention, in addition to the exercises included in the other conventional intervention group, is associated with an additional low-pressure abdominal exercise that will be performed in 10 minutes, therefore, the intervention in this group will have a total duration of 60 minutes. You are required to wear comfortable clothing and shoes during supervised and unsupervised training sessions for your safety.
Clinical trial: NCT05493319
Section: Purpose of Research
Subsections: 2. Brief Description Of The Project

The treatment of gynecological cancer is very important to increase the life expectancy of affected women. However, it can present secondary effects regarding fatigue and changes in pelvic floor strength related to symptoms of urinary incontinence, decreased sexual function and poor quality of life. However, little has been studied on remote kinesthetic management in women treated for gynecological cancer. The importance of the study is to generate information on the applicability of remote exercises in reducing or controlling the side effects of gynecological cancer treatment.
Clinical trial: NCT05493319
Section: Voluntary Participation
Subsections: I Agree To Participate In The Study ( ) Yes ( ) No Responsible Researcher

Ivana Leao **Ribeiro**
PhD in Physiotherapy, academic of Kinesiology Faculty of Health Sciences Universidad Católica del Maule
"Effects of hypopressive exercise associated with resistance and resistance training in the management of fatigue, urinary incontinence symptoms, sexual function and quality of life in women treated for gynecological cancer: a randomized clinical trial."
Catholic University of Maule Collaborators:
Francisca Valdivia Valeria Roteli Camila Rojas Nicolás Yáñez Francisco Ortega Lily Berríos Contreras It is hereby recorded that upon receipt of this document (informed consent) the participant must reply to the email or text/audio message stating "I accept" or "I do not accept" to participate in the study. This response will be recorded by the Responsible Investigator.