Hypopressive Exercise Associated With Strength and Resistance Training in Women Treated for Gynecological Cancer
Primary Purpose
Gynecologic Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Exercises
Sponsored by
About this trial
This is an interventional supportive care trial for Gynecologic Cancer focused on measuring Exercise Therapy, Neoplasms, Fatigue, Quality of Life, Urinary Incontinence
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
Sites / Locations
- Catholic University of Maule
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hypopresive, strength and resistance exercises
Strength and resistance exercises
Arm Description
Participants will perform 3 types of hypopresive exercises in the end of strength and resistance exercises intervention.
Participants will perform strength and resistance exercises intervention.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05493319
First Posted
July 9, 2022
Last Updated
August 5, 2022
Sponsor
Universidade Federal de Sao Carlos
1. Study Identification
Unique Protocol Identification Number
NCT05493319
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer
Keywords
Exercise Therapy, Neoplasms, Fatigue, Quality of Life, Urinary Incontinence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind randomized clinical trial: interventional group and usual care group
Masking
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.
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypopresive, strength and resistance exercises
Arm Type
Experimental
Arm Description
Participants will perform 3 types of hypopresive exercises in the end of strength and resistance exercises intervention.
Arm Title
Strength and resistance exercises
Arm Type
Active Comparator
Arm Description
Participants will perform strength and resistance exercises intervention.
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention 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.
Primary Outcome Measure Information:
Title
Change from baseline at 4 weeks in quality of life assessed by a questionnaire
Description
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.
Time Frame
Baseline/up to 4 weeks
Title
Change from baseline at 4 weeks in sexual function assessed by a questionnaire
Description
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.
Time Frame
Baseline/up to 4 weeks
Title
Change from baseline at 4 weeks in urinary incontinence assessed by a questionnaire
Description
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.
Time Frame
Baseline/up to 4 weeks
Title
Change from baseline at 4 weeks in fatigue assessed by a scale
Description
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.
Time Frame
Baseline/up to 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivana L Ribeiro, PhD
Phone
+56 712413622
Email
ivanaleao@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivana L Ribeiro, PhD
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Maule
City
Talca
State/Province
Maule
ZIP/Postal Code
3600000
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
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Hypopressive Exercise Associated With Strength and Resistance Training in Women Treated for Gynecological Cancer
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