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Trial Title:
Hypopressive Exercise Associated With Strength and Resistance Training in Women Treated for Gynecological Cancer
NCT ID:
NCT05493319
Condition:
Gynecologic Cancer
Conditions: Official terms:
Urinary Incontinence
Conditions: Keywords:
Exercise Therapy
Neoplasms
Fatigue
Quality of Life
Urinary Incontinence
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Single-blind randomized clinical trial: interventional group and usual care group
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
Outcome assessments before and after the intervention will be performed by a physical
therapist blinded to the allocation of participants in each group.
Intervention:
Intervention type:
Other
Intervention name:
Exercises
Description:
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.
Arm group label:
Hypopresive, strength and resistance exercises
Arm group label:
Strength and resistance exercises
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Catholic University of Maule
Address:
City:
Talca
Zip:
3600000
Country:
Chile
Start date:
March 1, 2023
Completion date:
July 30, 2023
Lead sponsor:
Agency:
Universidade Federal de Sao Carlos
Agency class:
Other
Source:
Universidade Federal de Sao Carlos
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05493319
