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临床试验/NCT07398313
NCT07398313已完成不适用

Effectiveness of Prehabilitation on Pelvic Function and Quality of Life Among Post-Surgical Cervical Cancer Women

Saveetha University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年6月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Change in Pelvic Floor Muscle Function Assessed by Transabdominal Ultrasound

研究概览

简要总结

This parallel-group randomized controlled trial evaluated the effectiveness of a four-week multimodal prehabilitation programme on pelvic function and quality of life among women with cervical cancer undergoing radical hysterectomy. Thirty-nine eligible participants were randomly allocated to either the intervention group or the control group. The intervention group received a supervised multimodal prehabilitation programme comprising aerobic exercise, pelvic floor muscle training, progressive resistance training, flexibility exercises, breathing exercises, and patient education for four weeks prior to surgery, while the control group received standard preoperative care. Following radical hysterectomy, both groups underwent an identical postoperative rehabilitation programme.

Pelvic function was assessed using transabdominal ultrasound by measuring bladder base displacement during voluntary pelvic floor muscle contraction. Pelvic floor symptoms were evaluated using the Pelvic Floor Distress Inventory-20 (PFDI-20), and health-related quality of life was assessed using a validated quality-of-life questionnaire. Outcome assessments were performed at baseline, four weeks before surgery prior to initiation of the intervention, and repeated four weeks after surgery. The study investigated whether a structured prehabilitation programme improved pelvic function, reduced pelvic floor-related symptoms, and enhanced postoperative quality of life compared with standard preoperative care among women undergoing radical hysterectomy for cervical cancer.

详细描述

This parallel-group, randomized controlled trial was conducted among women diagnosed with cervical cancer who were scheduled to undergo radical hysterectomy at a tertiary care teaching hospital. Eligible participants were consecutively recruited from the Department of Gynecologic Oncology after screening according to predefined inclusion and exclusion criteria. Written informed consent was obtained from all participants before enrollment.

A total of 34 eligible participants were randomly allocated in a 1:1 ratio to either the intervention group (n = 17) or the control group (n = 17) using a computer-generated randomization sequence prepared by an independent investigator. Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes that were opened only after participant enrollment. Owing to the nature of the intervention, blinding of participants and treating physiotherapists was not feasible. However, all outcome assessments were performed by an independent physiotherapist who was blinded to group allocation.

Baseline assessments (T0) were conducted four weeks before the scheduled surgery, prior to commencement of the intervention. The primary outcome was pelvic function, which was objectively assessed using transabdominal ultrasound (TAUS) by measuring bladder base displacement during maximal voluntary pelvic floor muscle contraction. Participants were instructed to attend the assessment with a comfortably filled bladder. The ultrasound transducer was positioned in the suprapubic region using a standardized protocol, and three maximal voluntary pelvic floor muscle contractions were performed with adequate rest between trials. The greatest bladder base displacement recorded during the three contractions was used for statistical analysis.

Secondary outcomes included pelvic floor symptoms assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) and disease-specific quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cervical Cancer Module (EORTC QLQ-CX24). The PFDI-20 is a validated patient-reported questionnaire comprising 20 items across urinary, colorectal-anal, and pelvic organ prolapse symptom domains, with higher scores indicating greater symptom severity and pelvic floor dysfunction. The EORTC QLQ-CX24 is a validated cervical cancer-specific quality-of-life questionnaire that evaluates symptom experience, body image, sexual functioning, sexual enjoyment, sexual and vaginal functioning, peripheral neuropathy, menopausal symptoms, lymphoedema, and treatment-related concerns, with scoring performed according to the EORTC scoring manual. Demographic and clinical characteristics including age, body mass index, menopausal status, FIGO stage, and relevant comorbidities were recorded at baseline.

Participants allocated to the intervention group underwent a supervised four-week multimodal prehabilitation programme before surgery. The programme was delivered five days per week, with each supervised session lasting approximately 60 minutes. The intervention comprised moderate-intensity aerobic exercise, pelvic floor muscle training, progressive resistance training for the upper and lower limbs using resistance bands, dumbbells, and weight cuffs, flexibility exercises, breathing exercises, and cool-down activities. Exercise intensity and progression were individualized according to each participant's baseline functional capacity and tolerance under the supervision of an experienced physiotherapist. Attendance and adherence were documented throughout the intervention period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged between forty and sixty years
  • Confirmed diagnosis of cervical cancer
  • Preoperative diagnosis of early-stage cervical cancer
  • Planned to undergo radical hysterectomy
  • Ability to actively engage in pelvic floor and resistance training protocols
  • Willingness to participate in the study
  • Provision of written informed consent prior to inclusion

排除标准

  • Diagnosis of locally advanced or metastatic cervical cancer
  • Presence of cardiopulmonary comorbidities limiting exercise tolerance
  • Active urinary tract infection at the time of assessment
  • Cognitive impairments interfering with understanding or compliance with the intervention
  • Any medical condition contraindicating participation in structured exercise programs

研究组 & 干预措施

Control Group

Active Comparator

The control group received conventional preoperative care for the same duration, which included free exercises, breathing exercises and walking, without structured resistance or pelvic floor-specific training.

干预措施: Conventional (Behavioral)

Prehabilitation Group

Experimental

The program consisted of three supervised sessions per day, each lasting 20 minutes, amounting to 60 minutes of daily exercise. Aerobic training included walking, cycling or treadmill exercises based on individual tolerance, pelvic floor muscle training was performed as two sets of ten repetitions focusing on proper activation and endurance and resistance training targeted upper and lower limb muscle groups using resistance bands, dumbbells, weight cuffs and a Swiss ball. Exercise intensity and progression were individualized according to each participant's functional capacity.

干预措施: Structured Prehabilitation Protocol (Behavioral)

结局指标

主要结局

Change in Pelvic Floor Muscle Function Assessed by Transabdominal Ultrasound

时间窗: Baseline (4 weeks before surgery) and 4 weeks following radical hysterectomy.

Pelvic function was assessed using transabdominal ultrasound (TAUS) by measuring bladder base displacement (BBD) during maximal voluntary pelvic floor muscle contraction. Participants were assessed in the supine position with a comfortably filled bladder using a standardized ultrasound protocol. Three maximal voluntary pelvic floor muscle contractions were performed, and the greatest bladder base displacement (measured in millimetres) was recorded for analysis. Greater cranial bladder base displacement indicated better pelvic floor muscle function.

Pelvic floor muscle strength using the Brink score

时间窗: baseline at four weeks prior surgery and post test assessment two week after surgery

The Brink Score was used to evaluate pelvic floor muscle strength. The Brink score is a digital vaginal palpation scale used to assess pelvic floor muscle function by evaluating pressure (strength), duration (endurance), and vertical displacement (lift). With the patient in supine or crook-lying position, a gloved finger is inserted vaginally and the patient is instructed to contract the pelvic floor muscles. Each component is scored from 0 to 4, giving a total score of 0-12. Scores of 0-3 indicate severe weakness, 4-6 moderate weakness, 7-9 fair strength and 10-12 strong pelvic floor muscles.

Functional performance using the Karnofsky Performance Scale

时间窗: baseline at four weeks prior surgery and post test assessment two week after surgery

The Karnofsky Performance Scale is a standardized tool used to assess a patient's functional status and ability to perform daily activities, particularly in oncology and chronic illness care. KPS is widely used to evaluate disease severity, prognosis, treatment tolerance, and eligibility for therapies, and to monitor changes in functional capacity over time.

Recovery efficiency through hospital stay duration

时间窗: baseline at four weeks prior surgery and post test assessment two week after surgery

The duration of hospital stay was used as a measure of recovery efficiency. It was calculated as the number of days from the date of surgery to the date of hospital discharge, as documented in medical records. Shorter hospital stay was interpreted as improved recovery and functional readiness for discharge.

次要结局

  • Change in Pelvic Floor Distress (PFDI-20)(Baseline (4 weeks before surgery) and 4 weeks after surgery.)
  • Change in Cervical Cancer-Specific Quality of Life (EORTC QLQ-CX24)(Baseline (4 weeks before surgery) and 4 weeks following radical hysterectomy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Akshya Sam

Principal Investigator, Post Graduate Student , Department of Community, Geriatric and Palliative care Physiotherapy, SIMATS college of Physiotherapy, SIMATS.

Saveetha University

研究点 (1)

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