Effect of Prehabilitation on Recovery Outcomes in Post-Surgical Cervical Cancer Women

NCT07398313 | Completed DMC

• 1 other identifier: 063/05/2025/ISRB/PGSR/SCPT
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Adenocarcinoma; Hysterectomy; Cervical Cancer

Keywords

Prehabilitation; Cervical Cancer; Pelvic floor; Functional performance; Recovery Efficiency; hysterectomy

Outcome Measures

Primary Outcomes (1)

• Change in Pelvic Floor Muscle Function Assessed by Transabdominal Ultrasound

  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.

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

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Behavioral: Structured Prehabilitation Protocol

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.

Behavioral: Conventional

Interventions

Structured Prehabilitation Protocol BEHAVIORAL

The prehabilitation intervention in this study is distinguished by its multimodal, time-bound and individualized design delivered during the preoperative window. Unlike conventional preoperative care, the program integrated aerobic conditioning, progressive resistance training and targeted pelvic floor muscle training with a structured 4-week protocol, providing 60 minutes of supervised daily exercise. Pelvic floor training emphasized correct muscle activation, endurance and coordination using standardized repetitions, while resistance exercises targeted both upper and lower limb muscle groups with graded external resistance. Exercise intensity and progression were individualized based on functional capacity, ensuring feasibility for women with moderate functional limitation. Both study groups received identical postoperative rehabilitation, allowing the isolated effect of prehabilitation on recovery outcomes,differentiating this intervention from other perioperative studies.

Prehabilitation Group

Conventional BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saveetha University: lead

Study Sites (1)

SaveethaUniversity

Chennai, Tamil Nadu, 602105, India

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Post Graduate Student , Department of Community, Geriatric and Palliative care Physiotherapy, SIMATS college of Physiotherapy, SIMATS.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 9, 2026
• Study Start: June 17, 2025
• Primary Completion: February 7, 2026
• Study Completion: April 22, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)