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Cervical AdenocarcinomaPROP-CCNCT07398313

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

A study testing Structured Prehabilitation Protocol and Conventional in people with Cervical Adenocarcinoma and Hysterectomy, run by Saveetha University at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 60 years, women only
What is being tested?
Structured Prehabilitation Protocol and Conventional
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteIndia
Study dates
17 Jun 2025to 22 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 informed consent prior to inclusion

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

India1 site
  • SaveethaUniversity

    Chennai, Tamil Nadu, 602105

Other trials in India

About this study

Official title: Effectiveness of Prehabilitation on Pelvic Function and Quality of Life Among Post-Surgical Cervical Cancer Women

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.

Being tested
Structured Prehabilitation Protocol, Conventional
Keywords
Prehabilitation, Cervical Cancer, Pelvic floor, Functional performance, Recovery Efficiency, hysterectomy
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured Prehabilitation ProtocolBehavioural

    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.

  • ConventionalBehavioural

    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.

Study groups in NCT07398313
Study groupRoleWhat they receive
Prehabilitation GroupExperimentalThe 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.
Receives: Behavioral: Structured Prehabilitation Protocol
Control GroupActive comparatorThe 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.
Receives: Behavioral: Conventional

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)
  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).

    Measured: 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start17 Jun 2025
  3. Primary completion7 Feb 2026
  4. Study completion22 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07398313
Sponsor's protocol ID
063/05/2025/ISRB/PGSR/SCPT
Acronym
PROP-CC
Status last verified
Jul 2026
First submitted
14 Jan 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Structured Prehabilitation Protocol and Conventional in people with Cervical Adenocarcinoma and Hysterectomy, run by Saveetha University at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pelvic Floor Muscle Function Assessed by Transabdominal Ultrasound (time frame: Baseline (4 weeks before surgery) and 4 weeks following radical hysterectomy.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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