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

NCT05493319 | Unknown

• 1 other identifier: UCM
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. .

Conditions

Gynecologic Cancer

Keywords

Exercise Therapy; Neoplasms; Fatigue; Quality of Life; Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Hypopresive, strength and resistance exercises

EXPERIMENTAL

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

Other: Exercises

Strength and resistance exercises

ACTIVE COMPARATOR

Participants will perform strength and resistance exercises intervention.

Other: Exercises

Interventions

Exercises 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.

Hypopresive, strength and resistance exercises; Strength and resistance exercises

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Catholic University of Maule

Talca, Maule Region, 3600000, Chile

Location

MeSH Terms

Conditions

Neoplasms; Fatigue; Urinary Incontinence

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ivana L Ribeiro, PhD

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivana L Ribeiro, PhD

CONTACT

+56 712413622; ivanaleao@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments before and after the intervention will be performed by a physical therapist blinded to the allocation of participants in each group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-blind randomized clinical trial: interventional group and usual care group

Study Record Dates

• First Submitted: July 9, 2022
• First Posted: August 9, 2022
• Study Start: March 1, 2023
• Primary Completion: May 30, 2023
• Study Completion: July 30, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)