Clinical trial NCT05493319: Hypopressive Exercise Associated With Strength and Resistance Training in Women Treated for Gynecological Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Cancer
Keywords: Exercise Therapy
Neoplasms
Fatigue
Quality of Life
Urinary Incontinence
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized clinical trial: interventional group and usual care group
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline at 4 weeks in quality of life assessed by a questionnaire
timeFrame: Baseline/up to 4 weeks
measure: Change from baseline at 4 weeks in sexual function assessed by a questionnaire
timeFrame: Baseline/up to 4 weeks
measure: Change from baseline at 4 weeks in urinary incontinence assessed by a questionnaire
timeFrame: Baseline/up to 4 weeks
measure: Change from baseline at 4 weeks in fatigue assessed by a scale
timeFrame: Baseline/up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Talca
country: Chile
facility: Catholic University of Maule
state: Maule
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Ivana L Ribeiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: