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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (4 weeks before surgery) and 4 weeks following radical hysterectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 0 to 300, with higher scores indicating greater symptom severity and pelvic floor-related distress. |
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Inclusion Criteria:
Exclusion Criteria:
female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SaveethaUniversity | Chennai | Tamil Nadu | 602105 | India |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 14, 2026 | Jul 4, 2026 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| 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. |
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| Baseline (4 weeks before surgery) and 4 weeks after surgery. |
| 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. Scores were calculated according to the EORTC scoring manual. For functional scales, higher scores indicate better functioning, whereas for symptom scales, higher scores indicate greater symptom burden. | Baseline (4 weeks before surgery) and 4 weeks following radical hysterectomy |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |