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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from baseline at 4 weeks in sexual function assessed by a questionnaire
研究概览
简要总结
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. .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessments before and after the intervention will be performed by a physical therapist blinded to the allocation of participants in each group.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline at 4 weeks in sexual function assessed by a questionnaire
时间窗: Baseline/up to 4 weeks
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
时间窗: Baseline/up to 4 weeks
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 quality of life assessed by a questionnaire
时间窗: Baseline/up to 4 weeks
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 fatigue assessed by a scale
时间窗: Baseline/up to 4 weeks
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.
次要结局
未报告次要终点
研究者
Ivana Leão Ribeiro
Principal Investigator
Universidade Federal de Sao Carlos