Accelerometer Measured Early Recovery After Prolapse Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorNICHD Pelvic Floor Disorders Network

About this trial

The AccelERate study will evaluate the physical recovery of patients who have undergone Pelvic Organ Prolapse (POP) surgery. This will be evaluated via a self-reported recovery questionnaire completed daily. Participants will wear an accelerometer device on their non-dominant wrist and be given either routine or exercise-focused postoperative instructions. The primary outcome will be a comparison of the number of days needed to reach self-reported "mostly recovered" status between randomly assigned instruction groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject has provided written informed consent

Ambulatory women undergoing laparoscopic, robotic, or vaginal reconstructive or obliterative surgery for apical prolapse

POP-Q >= Stage III

Willing to participate in a postoperative exercise regimen

Disqualifiers

Inability or unwillingness to adhere to the exercise intervention

Contraindication to medium-intensity exercise

Comorbidities preventing physical activity

Planned abdominal approach with laparotomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Postoperative Exercise regimen

    Behavioral

    The intervention arm will be instructed to perform 30 minutes of medium intensity exercise (vigorous enough to cause shortness of breath, but light enough to be able to maintain a conversation) starting on postoperative day 3 and continuing at least 5 times weekly for 6 weeks. Participants in the intervention group will be allowed to select their preferred physical activity, and the activity will be performed without supervision. Participants in the control group will be given typical postoperative instructions with gradual resumption of activity.

Treatment groups

288 Participants
are divided into 2 treatment groups
Group A: Standard of CareNo intervention 0 interventions
Group B: Postoperative Exercise regimenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recovery Status

A participant will be considered "mostly recovered" if they report feeling "mostly" or "completely" recovered on 2 consecutive daily self-report occasions, allowing for skipped days. The primary outcome will be number of days since surgery at which the participant first reports feeling mostly recovered, provided they confirm that status on the next consecutive occasion.

Time frame
From Day 3 post operation to 12 weeks post operation OR until participant achieves Mostly Recovered Status, whichever occurs first.

Secondary outcomes

1

Adherence to Exercise

To measure adherence to a prescribed early exercise regimen using accelerometry for 6 weeks postoperatively and to determine if there is a difference in activity based on accelerometer data through 6 weeks postoperatively between women in the prescribed exercise regimen group versus those in the standard postoperative activity instruction group.

Time frame
From baseline to 6 weeks post operation.
2

Change From Baseline PFDI-20 Score

The Pelvic Floor Distress Inventory (PFDI-20) is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an Overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100) and, 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI-20 is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI-20 scale. Change from baseline = (Week\[2,6,12\] Score - Baseline Score).

Time frame
From baseline to 12 weeks post operation
3

Change From Baseline PFIQ-7 Score

The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFI-7Q is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ-7 score. Change from baseline = (Week\[2,6,12\] - Baseline Score).

Time frame
From baseline to 12 weeks post operation
4

PGI-I Score

The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived condition improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse).

Time frame
From 12 weeks post operation to 1 year post operation

Other outcomes

1

Longitudinal Outcomes - Change From Baseline PFDI-20 Score

The Pelvic Floor Distress Inventory (PFDI-20) is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an Overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI-20 is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI-20 scale. Change from baseline = (Year 1 Score - Baseline Score).

Time frame
Baseline to 1 year post-operation
2

Longitudinal Outcomes - Change From Baseline PFIQ-7 Score

The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ-7 is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ-7 score. Change from baseline = (Year 1 - Baseline Score).

Time frame
Baseline to 1 year post-operation
3

Longitudinal Outcomes - Change From Baseline AAS Score

The Activity Assessment Scale (AAS) is a is a standardized a measure of functional activity. The score ranges from 0 to 100 with higher scores indicating greater functional activity.

Time frame
Baseline to 1 year post-operation
4

Longitudinal Outcomes - Change From Baseline NRS Score

The Numeric Rating Scale (NRS) is a one-question validated patient-reported measure that quantifies the intensity of a specific symptom or experience on a numeric scale, from 0 (no pain) to 10 (worst pain imaginable). Higher scores are worse.

Time frame
Baseline to 1 year post-operation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NICHD Pelvic Floor Disorders Network

Lead sponsor

RTI International

Collaborator

University of California, San Diego

Collaborator

University of Chicago

Collaborator

Duke University

Collaborator

Women and Infants Hospital of Rhode Island

Collaborator

University of Pennsylvania

Collaborator

Kaiser Permanente

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator