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 randomized controlled trial was conducted among patients diagnosed with cervical cancer and scheduled to undergo radical hysterectomy. A total of 34 participants were recruited using a simple random sampling technique after obtaining approval from the Institutional Ethics Committee. Participants were screened based on predefined selection criteria to ensure safety, reliability of outcome measures and avoidance of confounding medical conditions. Eligible patients were informed in detail about the study, and written informed consent was obtained prior to enrollment. Participants were randomly allocated into two equal groups (n = 17 each) using the lottery method, with allocation concealment maintained to minimize selection bias. Baseline assessments were carried out four weeks prior to surgery and included evaluation of pelvic floor muscle strength using the Brink score, functional status using the Karnofsky Performance Scale and anticipated duration of hospital stay as an indicator of recovery efficiency. The intervention group underwent a structured prehabilitation exercise program for four weeks before surgery, consisting of three supervised daily sessions totaling 60 minutes. The program included aerobic training, targeted pelvic floor muscle strengthening and upper and lower limb resistance training, with exercise intensity and progression individualized according to the participant's functional capacity. The control group received a generalized standard exercise protocol comprising free exercises, breathing exercises and walking, delivered with similar session duration but without structured resistance or pelvic floor-specific training. Postoperatively, both groups received a standardized rehabilitation program for two weeks, including breathing exercises, pelvic floor strengthening and core stabilization exercises to promote early mobilization and prevent complications. Post-intervention assessments were conducted after two weeks to evaluate the effectiveness of the intervention. The study utilized basic exercise and assessment equipment, including resistance bands, weight cuffs, dumbbells, a Swiss ball, a couch and a stopwatch.

Conditions

Cervical Adenocarcinoma; Hysterectomy; Cervical Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Pelvic floor muscle strength using the Brink score

  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.

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

• Functional performance using the Karnofsky Performance Scale

  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.

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

• Recovery efficiency through hospital stay duration

  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.

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

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
• Karnofsky Performance Scale score between 50 and 70
• 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.

Model Details: This randomized controlled,evaluated the effectiveness of prehabilitation on pelvic floor weakness, functional performance and recovery efficiency in post-surgical cervical cancer women. The study was conducted in the inpatient and outpatient departments of a hospital. Women aged 40-60 years with early-stage cervical cancer scheduled for radical hysterectomy and a Karnofsky Performance Scale score of 50-70 were eligible. Of 46 patients screened, 39 were randomized using the lottery method into a prehabilitation group (n = 19) or control group (n = 20). Baseline assessments included Brink score, Karnofsky Performance Scale and hospital stay. The prehabilitation group received four weeks of structured aerobic, resistance and pelvic floor exercises, while controls received conventional care. Both groups underwent identical postoperative rehabilitation. Post-test assessment followed two weeks post-surgery. Non-parametric analysis was performed (p \< 0.05). No adverse events were reported.

Study Record Dates

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

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)