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CompletedNCT07398313PROP-CCUpdated Jul 16, 2026

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

An interventional study of Structured Prehabilitation Protocol and Conventional in Cervical Adenocarcinoma, Hysterectomy and Cervical Cancer, sponsored by Saveetha University. Completed at 1 site in India. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Saveetha University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jun 2025, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 61 studies in Uterine Cervical Neoplasms with a site in India — 17 open to participants now, 21 under way, 3 of them phase 3. Uterine Cervical Neoplasms · India.

Enrollment
42nd of 44
34 · median 311
Started
2025
with 4 others
No phase
19 of 61
6 open now
Registered
58th of 61
by date

Among the 61 studies in Uterine Cervical Neoplasms with a site in India, this one is the 42nd largest by enrollment of the 44 interventional ones that give a count, is one of 5 that started in 2025, is one of 19 with no phase, and was the 58th registered.

Uterine Cervical Neoplasms

2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.

Browse Uterine Cervical Neoplasms studies →

Open to participants now

17 of the 61 studies in Uterine Cervical Neoplasms with a site in India are open now. Recruiting first, the newest first:

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All 17 open studies →

A study can be open while its sites in India have not opened yet or have stopped. Only those recruiting at a site in India →

Who these studies take

Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.

This study: 40 Years to 60 Years · female · no healthy volunteers.

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02

Study 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.

Read the detailed description

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.

Participants allocated to the control group received the institution's standard preoperative physiotherapy programme consisting of breathing exercises, active range-of-motion exercises, postural education, and walking advice of comparable duration. No structured multimodal exercise programme, pelvic floor muscle training, or progressive resistance training was provided during the preoperative period.

Following completion of the four-week intervention period, all participants underwent radical hysterectomy according to the institution's standard surgical protocol. After surgery, both groups received an identical standardized postoperative rehabilitation programme for four weeks, including breathing exercises, early mobilization, progressive ambulation, lower-limb strengthening, core stabilization exercises, and conventional postoperative physiotherapy in accordance with institutional practice. No additional supervised prehabilitation sessions were delivered during the postoperative period.

Outcome assessments (T1) were repeated four weeks after surgery by the same blinded assessor using identical assessment procedures. Pelvic function was reassessed using transabdominal ultrasound, pelvic floor symptoms were reassessed using the PFDI-20, and quality of life was reassessed using the EORTC QLQ-CX24. Participant adherence, postoperative complications, adverse events, and withdrawals were documented throughout the study.

Statistical analyses were performed using IBM SPSS Statistics. Descriptive statistics were used to summarize participant characteristics and outcome measures. Continuous variables were expressed as mean ± standard deviation , depending on data distribution, while categorical variables were presented as frequencies and percentages. Normality of continuous variables was assessed using the Shapiro-Wilk test. Baseline characteristics between groups were compared using appropriate tests. Changes in pelvic function, pelvic floor symptoms, and quality-of-life outcomes within and between groups were analyzed using appropriate statistical methods. Effect sizes and 95% confidence intervals were reported where appropriate, and statistical significance was established at a two-sided p-value of less than 0.05.

03

Conditions studied

  • Cervical Adenocarcinoma
  • Hysterectomy
  • Cervical Cancer

Keywords

  • Prehabilitation
  • Cervical Cancer
  • Pelvic floor
  • Functional performance
  • Recovery Efficiency
  • hysterectomy
04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 prior to inclusion

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of locally advanced or 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Prehabilitation Group

    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

  • Active comparator
    Control Group

    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

  • BehavioralStructured 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.

  • BehavioralConventional

    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.

06

What researchers measure

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.

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

Secondary outcomes

  1. Change in Pelvic Floor Distress (PFDI-20)

    Pelvic floor symptoms were assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20), a validated 20-item patient-reported outcome measure evaluating urinary, colorectal-anal, and pelvic organ prolapse symptoms. Responses were converted to standardized scores ranging from a minimum value of 0 to a maximum value of 300, where higher scores indicate greater symptom severity and pelvic floor-related distress (a worse outcome).

    Time frame: Baseline (4 weeks before surgery) and 4 weeks after surgery.

  2. Change in Cervical Cancer-Specific Quality of Life (EORTC QLQ-CX24)

    Quality of life was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC QLQ-CX24). The questionnaire evaluates cervical cancer-specific symptoms and concerns, including symptom experience, body image, sexual and vaginal functioning, peripheral neuropathy, menopausal symptoms, lymphoedema, and sexual worry. All subscale and single-item scores were linearly transformed according to the EORTC scoring manual to range from a minimum value of 0 to a maximum value of 100. For functional scales, higher scores indicate better functioning (a better outcome), whereas for symptom scales, higher scores indicate greater symptom burden (a worse outcome).

    Time frame: Baseline (4 weeks before surgery) and 4 weeks following radical hysterectomy

07

Study locations

1 site
  • SaveethaUniversity
    Chennai, Tamil Nadu 602105, India
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2025 to primary completion in Feb 2026, 7 months.

Of 446 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's 7 months is below that.

Counting every sponsor, half of 462 studies reached it within 33 months; a quarter within 15 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2026
First posted
Feb 9, 2026
StartActual
Jun 17, 2025
Primary completionActual
Feb 7, 2026
CompletionActual
Apr 22, 2026
Last update
Jul 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07398313
Lead sponsor
Saveetha University
Responsible party
Akshya Sam (Principal Investigator, Post Graduate Student , Department of Community, Geriatric and Palliative care Physiotherapy, SIMATS college of Physiotherapy, SIMATS., Saveetha University) — Principal investigator
First posted
Feb 9, 2026
Start date
Jun 17, 2025
Primary completion
Feb 7, 2026
Completion
Apr 22, 2026
Last update
Jul 16, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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