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

Effects of Hypopressive Exercise Associated With Strength and Resistance Training in the Management of Fatigue, Urinary Incontinence Symptoms, Sexual Function and Quality of Life in Women Treated for Gynecological Cancer

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. .

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Other: Exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivana L Ribeiro, PhD; Phone Number: +56 712413622; Email: ivanaleao@gmail.com

Study Locations

• Chile
  • Maule
    • Talca, Maule, Chile, 3600000
      • Catholic University of Maule

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hypopresive, strength and resistance exercises; Participants will perform 3 types of hypopresive exercises in the end of strength and resistance exercises intervention.	Other: 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.
ACTIVE_COMPARATOR: Strength and resistance exercises; Participants will perform strength and resistance exercises intervention.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline at 4 weeks in quality of life assessed by a questionnaire	Data are be collected using the questionnaire The European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire it contains 30 items and the total score ranges from 0 (very poor) to 100 (excellent) for the functional dimensions, and from 0 (excellent) to 100 (very poor) for the symptom dimensions. All of the multi-item scales and single-item measures range in a score from 0 to 100, where a high score represents a higher response level.	Baseline/up to 4 weeks
Change from baseline at 4 weeks in sexual function assessed by a questionnaire	Data are be collected using the questionnaire Organ Prolapse/Urinary Incontinence Sexual Questionnaire that consists of 12 items, the scores range from 0 to 48, the higher the score, the better the sexual function.	Baseline/up to 4 weeks
Change from baseline at 4 weeks in urinary incontinence assessed by a questionnaire	Data are be collected using the questionnaire Pelvic Floor Impact Questionnaire-Short Form 7 that score corresponds to 0: not at all; 1: something; 2: moderately and 3: quite a bit. For the conversion of the score, the mean score must be multiplied with 100/3 and a scale range of 0 to 100 is obtained, the higher the score, the greater the impact of symptoms on general activities.	Baseline/up to 4 weeks
Change from baseline at 4 weeks in fatigue assessed by a scale	Data are be collected using the scale the Brief Fatigue Inventory that it is made up of 3 items, the categorization of fatigue levels can be obtained through an arithmetic average of the scores obtained in each item. Score 0 means "no fatigue"; 1-3: "mild fatigue"; 4-6: "moderate fatigue" and 7-10: "severe fatigue.	Baseline/up to 4 weeks

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Investigators: Principal Investigator: Ivana L Ribeiro, PhD, Universidade Federal de Sao Carlos

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2023
• Primary Completion (ANTICIPATED): May 30, 2023
• Study Completion (ANTICIPATED): July 30, 2023

Study Registration Dates

• First Submitted: July 9, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (ACTUAL): August 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life; Neoplasms; Fatigue; Exercise Therapy; Urinary Incontinence
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: UCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No