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

NCT07398313 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-02-09

No results posted yet for this study

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

Interventions

BEHAVIORAL

Structured Prehabilitation Protocol

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.

BEHAVIORAL

Conventional

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.

Sponsors & Collaborators

  • Saveetha University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2025-10-07
Completion
2025-11-22

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07398313 on ClinicalTrials.gov