Effectiveness Of Prehabilitation On Pelvic Floor Weakness, Functional Performance And Recovery Efficiency Among Post-Surgical Cervical Cancer Women
Phase: NA
Conditions: Cervical Adenocarcinoma, Hysterectomy, Cervical Cancer
Sponsor: Saveetha University

TITLE:
EFFECTIVENESS
OF
PREHABILITATION
ON
PELVIC
FLOOR
WEAKNESS, FUNCTIONAL PERFORMANCE AND RECOVERY EFFICIENCY
AMONG POST SURGICAL CERVICAL CANCER WOMEN
NCT: Not yet assigned
Unique Protocol Id: 063/05/2025/ISRB/PGSR/SCPT
Document Date: 2025.05.09
Subjects: Patients with cervical cancer undergoing radical hysterectomy.
Sampling technique: Simple random sampling technique.
Sample size: 34
Selection criteria
The selection criteria for the present study were carefully formulated to ensure the
inclusion of participants who could safely undergo the intervention and provide
reliable outcome data, while excluding individuals with conditions that could
confound the results or pose medical risks. The criteria were applied uniformly during
participant screening prior to enrollment.
Inclusion Criteria
Women aged between 40 and 60 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
Provision of written informed consent prior to inclusion
Exclusion Criteria
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
intervention

Any medical condition contraindicating participation in structured exercise programs
Study procedure
After obtaining approval from the Institutional Ethics Committee, the study was
conducted as a randomized controlled trial among patients diagnosed with cervical
cancer and scheduled to undergo radical hysterectomy. The study setting included the
inpatient and outpatient departments. Potential participants were screened by the
investigator based on the predefined inclusion and exclusion criteria. Eligible
participants were approached individually and a detailed explanation of the study
objectives, procedures, potential benefits and possible risks was provided in a
language understandable to them. Adequate time was given for clarification of doubts
following which written informed consent was obtained prior to enrolment in the
study.
A total of 34 participants who satisfied the selection criteria were included. Simple
random sampling was adopted for participant selection and random allocation into
two groups was carried out using the lottery method to ensure unbiased group
assignment. The participants were equally divided into two groups, the intervention
group and the control group, with 17 participants in each group. Allocation
concealment was maintained throughout the recruitment process to minimize
selection bias.
Baseline assessments were conducted four weeks prior to the scheduled surgical
procedure. Pre-test measurements included assessment of pelvic floor muscle strength
using the Brink score, evaluation of overall functional status using the Karnofsky
Performance Scale and assessment of recovery efficiency through the anticipated
duration of hospital stay. All baseline assessments were performed before the
commencement of the exercise intervention to ensure uniformity in data collection.
Participants allocated to the intervention group underwent a structured prehabilitation
exercise program for a duration of four weeks prior to surgery. The prehabilitation
protocol consisted of three supervised sessions per day, each lasting 20 minutes,
amounting to a total of 60 minutes of exercise daily. The first session focused on
aerobic training, which included activities such as walking, cycling and treadmill
exercises based on the individual’s choice, tolerance and fitness level. The second
session emphasized pelvic floor muscle strengthening exercises, which were
individualized and performed as two sets of ten repetitions to improve pelvic floor
muscle activation and endurance. The third session consisted of resistance training
exercises targeting both upper and lower limb muscle groups using appropriate
equipment also performed as two sets of ten repetitions. Exercise intensity and
progression were individualized based on the participant’s functional capacity and
clinical status.
Participants in the control group received a generalized standard exercise protocol for
four weeks prior to surgery. This protocol included free exercises, breathing exercises

and walking, delivered in three daily sessions similar in duration to the intervention
group. However, no structured or targeted prehabilitation components such as
resistance training or specific pelvic floor muscle strengthening were included in the
control protocol.
Following surgery, participants in both groups underwent standardized postoperative
rehabilitation for a period of two weeks. Postoperative rehabilitation included
breathing exercises, pelvic floor strengthening exercises such as Kegel exercises and
pelvic bridging
and
core strengthening
exercises
aimed at
promoting early
mobilization,
improving
functional
recovery
and
preventing
postoperative
complications. The postoperative rehabilitation protocol was uniform for both groups
to ensure comparability. Post-intervention assessments were conducted as per the
study timeline after two weeks to evaluate the effectiveness of the intervention.
Materials Required
The materials required for the study included basic exercise and assessment
equipment. For the intervention group, resistance bands, weight cuffs, dumbbells and
a Swiss ball were used to perform aerobic, resistance and pelvic floor strengthening
exercises. For outcome assessment, a couch and a stopwatch were used to facilitate
standardized functional and pelvic floor muscle evaluations.
Outcome measures
To evaluate the effectiveness of the prehabilitation program on functional status,
pelvic floor muscle performance, and recovery efficiency, standardized and clinically
validated outcome measures were utilized. These measures were selected to
comprehensively capture both functional and physiological changes associated with
the intervention and to allow objective comparison between the intervention and
control groups across the study period.
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.
Karnofsky Performance Scale: The Karnofsky Performance Scale (KPS) 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.

Duration of hospital: 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.
Data Analysis
The collected data were analyzed using SPSS with a significance level set at p < 0.05.
Normality of continuous variables was assessed using the Shapiro–Wilk test, which
indicated a non-normal distribution of the primary outcome measures, including Brink
score and Karnofsky Performance Status (KPS). Due to the non-parametric nature of
the data, within-group comparisons of pre and post-intervention scores were
performed using the Wilcoxon signed-rank test, which is appropriate for evaluating
paired differences in related samples when the assumption of normality is not met.
Between-group comparisons at baseline and post-intervention were conducted using
the Mann–Whitney U test, a non-parametric alternative to the independent samples t-
test, suitable for comparing two independent groups with skewed data. Effect sizes
were calculated to determine the clinical significance of observed changes in outcome
measures.Recovery efficiency measured as hospital stay duration was summarized
using descriptive statistics specifically mean and standard deviation to reflect the
overall trend in postoperative recovery between groups. This combination of non-
parametric tests and descriptive statistics ensured accurate and robust evaluation of
the intervention’s impact on pelvic floor strength, functional performance and
recovery outcomes among post-surgical cervical cancer women.

INFORMED CONSENT FORM
SAVEETHA COLLEGE OF PHYSIOTHERAPY
SIMATS, CHENNAI-602105
Informed Consent Form
I----------------------------------------------------Agree
to
take
part
in
the
study
conducted by Akshya S post graduate student of Saveetha College of Physiotherapy,
SIMATS.
TITLE: : Effectiveness of Prehabilitation on Pelvic Floor Weakness and Quality of
Life Among Cervical Cancer Population Undergoing Hysterectomy.
I acknowledge that the study has been explained to me and I agree to participate and I
am willing to provide information about my health status to the investigator. I allow
the investigator to have access to my medical records, pertaining to the purpose of the
study. Participate in the analysis program. Make myself available for further analysis
required. I have been informed about the purpose producers and measurements
involved in the study and my queries towards the study have been clarified. I have
been informed that this study consists of a grouping and I also agree to come regularly
for the study period of 6 weeks.
I Provide consent to the investigator to use the still photographs with masked face for
educational purposes only. No funds / fees / remuneration is taken from the subjects
on the course of the study.
I understand that my participation is voluntary and can with draw at any stage of the
study.
Place:
Date:
Signature