Hypopressive Exercise Associated With Strength and Resistance Training in Women Treated for Gynecological Cancer

NCT ID: NCT05493319

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-07-30

Brief Summary

The study aims to evaluate the effects of 4 weeks of hypopressive exercise associated with resistance training and aerobic exercises on fatigue, symptoms of urinary incontinence, sexual function and quality of life in women treated for gynecological cancer compared to a group that will perform conventional training. .

Detailed Description

Objective: To evaluate the effects of 4 weeks of hypopressive exercise associated with resistance training and aerobic exercises on fatigue, symptoms of urinary incontinence, sexual function and quality of life in women treated for gynecological cancer compared to a group that will perform conventional training.

Methods: This will be a single-blind randomized clinical trial. A hypopressive exercise intervention associated with resistance training and aerobic exercise will be carried out during twelve telerehabilitation sessions. Patients over 18 years of age who are diagnosed with gynecological cancer and who are indicated for radiotherapy or chemotherapy will participate. Patients will be randomly assigned to an experimental group of hypopressive exercises associated with resistance training and aerobic exercises or conventional training. Fatigue, quality of life, symptoms of urinary incontinence and sexual function will be evaluated before and after the intervention.

Discussion: The results of this clinical trial will determine the impact of conventional training associated with hypopressive exercise on the negative side effects of cancer treatment in women with gynecological cancer.

Conditions

Gynecologic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Hypopresive, strength and resistance exercises

Participants will perform 3 types of hypopresive exercises in the end of strength and resistance exercises intervention.

Group Type: EXPERIMENTAL

Exercises

Intervention Type: OTHER

Both groups will train three times a week, twice synchronously online and once asynchronously, considering a standardized exercise guideline. In all intervention sessions, conventional exercises will be guided by the standardized exercise guideline previously developed by the study team, for 4 weeks. Hypopresive, strength and resistance exercises group will receive static hypopressive exercise in supine position, with variant of arms in flexion, abduction and extension, consisting of 3 exercises at the end of the intervention with strength and resistance exercises.

Strength and resistance exercises

Participants will perform strength and resistance exercises intervention.

Group Type: ACTIVE_COMPARATOR

Exercises

Intervention Type: OTHER

Both groups will train three times a week, twice synchronously online and once asynchronously, considering a standardized exercise guideline. In all intervention sessions, conventional exercises will be guided by the standardized exercise guideline previously developed by the study team, for 4 weeks. Hypopresive, strength and resistance exercises group will receive static hypopressive exercise in supine position, with variant of arms in flexion, abduction and extension, consisting of 3 exercises at the end of the intervention with strength and resistance exercises.

Interventions

Exercises

Both groups will train three times a week, twice synchronously online and once asynchronously, considering a standardized exercise guideline. In all intervention sessions, conventional exercises will be guided by the standardized exercise guideline previously developed by the study team, for 4 weeks. Hypopresive, strength and resistance exercises group will receive static hypopressive exercise in supine position, with variant of arms in flexion, abduction and extension, consisting of 3 exercises at the end of the intervention with strength and resistance exercises.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Candidates must have a medical diagnosis of gynecological cancer
• Participants should have an indication for chemotherapy or radiotherapy, associated or not with pelvic lymphadenectomy
• Women with an age range over 18 years with a limit of up to 60 years
• Participants who are able to practice physical activity

Exclusion Criteria

• Recurrence of gynecological cancer
• Presence of lymphedema in the lower limb, measured by cytometry of the lower limb with a tape measure; asymmetries of more than 2 cm between the limbs were considered edema
• Diagnosis of metastasis
• Heart disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Ivana Leão Ribeiro

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivana L Ribeiro, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Sao Carlos

Locations

Catholic University of Maule

Talca, Maule Region, Chile

Countries

Chile

Central Contacts

Ivana L Ribeiro, PhD

Role: CONTACT

ivanaleao@gmail.com

+56 712413622

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UCM

Identifier Type: -

Identifier Source: org_study_id