Supervised Exercise for Interstitial Cystitis
(IC/BPS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Bladder cancer, Stroke, Multiple sclerosis, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
In this study, the efficacy of exercise to improve interstitial cystitis/bladder pain syndrome symptoms and quality of life will be investigated.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is supervised exercise generally safe for humans?
How does the exercise regimen treatment for interstitial cystitis differ from other treatments?
The exercise regimen for interstitial cystitis is unique because it focuses on physical activity to potentially improve symptoms, unlike other treatments that may involve medication or surgical options. This approach is similar to exercise programs used in other conditions like interstitial lung disease, where exercise has been shown to improve exercise capacity and quality of life.678910
Eligibility Criteria
This trial is for English-speaking adult women aged 18-80 with a diagnosis of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), confirmed by a specialist. Participants must be able to walk without assistance and tolerate moderate exercise, not pregnant, and free from certain conditions like bladder cancer or neurological disorders.Inclusion Criteria
Must speak English
I am a woman aged 18-79 with diagnosed interstitial cystitis/bladder pain.
I have been diagnosed with bladder pain syndrome as per the American Urological Association Guidelines.
See 1 more
Exclusion Criteria
I can do moderate exercise and have been active for 90 minutes a week.
I can walk without any help from devices like canes or wheelchairs.
Pregnant women are not eligible for this study
See 1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Participants complete baseline surveys and provide urine samples for biomarker analysis
1 week
1 visit (in-person)
Exercise Treatment
Participants undergo a supervised exercise program to relieve pain and improve symptoms
4 months
Weekly sessions (in-person)
Post-regimen Review
Participants are contacted to provide feedback on the exercise program and discuss continued exercise
1 week
1 contact (phone or email)
Follow-up
Participants are monitored for changes in symptoms and inflammatory biomarkers after the exercise program
4 weeks
Treatment Details
Interventions
- Exercise regimen (Behavioral Intervention)
Trial OverviewThe study tests whether a supervised exercise regimen can alleviate symptoms of IC/BPS and improve the quality of life in patients. It explores the effectiveness of physical activity as part of treatment for this chronic bladder condition.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Exercise treatment groupExperimental Treatment1 Intervention
This group will serve as both their own controls and study subjects for the experimental intervention. They will take surveys to record bladder symptoms and quality of life before undergoing exercise. They will then take the same surveys after exercise and their scores will be compared.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest University Health SciencesWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
UNC GreensboroCollaborator
University of North Carolina, GreensboroCollaborator
References
Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]For high-risk individuals and their healthcare providers, finding the right balance between promoting physical activity and minimizing the risk of adverse events can be difficult. More information on the prevalence and influence of adverse events is needed to improve providers' ability to prescribe effective and safe exercise programs for their patients.
Sudden cardiac death associated with exercise: the risk-benefit issue. [2019]Although there is an overall increased risk of sudden cardiac death associated with physical exertion, the risk is small. Yet it warrants consideration by physicians and their adult patients who pursue exercise because, in any individual patient, the risk may be high. To advise patients properly on the risks and benefits of exercise, physicians should have an understanding of the risks of exercise, a strategy for patient evaluation that effectively identifies patients at risk, and a knowledge of appropriate exercise procedures that minimize risk. Patients should also know proper exercise procedures, be aware that there is some degree of risk in exercise, know their exercise tolerance, understand self-monitoring procedures, and be sensitive to prodromal symptoms. The essential feature of prudent exercise is a gradual progression during which an individual remains well within the limits of his/her exercise tolerance.
Quality of reporting and nature of harms in clinical trials on supervised exercise in patients with rheumatoid arthritis or axial spondyloarthritis. [2023]To describe the quality of reporting and the nature of reported harms in clinical studies on the effectiveness of supervised exercises in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). We performed a systematic review, searching eight databases up to February 2023. Randomized controlled trials (RCTs) evaluating supervised exercises in adults with RA or axSpA were considered eligible. Data on harms were extracted according to the CONSORT Harms 2022 Checklist. Among others, it was recorded if harms were prespecified or non-prespecified. Moreover, the nature of reported harms was listed. Forty RCTs were included for RA and 25 for axSpA, of which 29 (73%) and 13 (52%) reported information on harms. In 13 (33%) RCTs in RA and four (16%) in axSpA, the collection of harms outcomes was described in the methods section. Prespecified outcomes were reported by eight (RA) and two (axSpA) RCTs. Non-specified harms outcomes were reported by six (RA) and four (axSpA) RCTs. Prespecified harms outcomes included measures of pain, disease activity, inflammation, and structural joint changes. The nature of non-prespecified harms outcomes varied largely, with pain being most common. A considerable proportion of trials on supervised exercise in RA or axSpA does not or inadequately report harms outcomes. Pain was the most commonly reported prespecified or non-specified harm. For a considerate interpretation of the balance between benefits and harms of supervised exercise in RA or axSpA, use of the CONSORT Harms 2022 Checklist for the design, conduct and reporting of trials is advocated.
Is it safe to exercise during oncological treatment? A study of adverse events during endurance and resistance training - data from the Phys-Can study. [2021]Few studies have systematically evaluated the risk of adverse events (AEs) among persons exercising during oncological treatment. We aimed to describe incidence and types of AEs during exercise for persons undergoing oncological treatment, and associations to exercise intensity, exercise adherence, chemotherapy treatment, initial aerobic fitness. A second aim was to compare incidence of lymphedema, periphery inserted central catheter (PICC) complications, and other new medical conditions (any illness or injury occurred during the exercise trial) between high-intensity vs low-to-moderate exercise and usual care (UC).
Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]Researchers who conduct physical activity (PA) intervention studies provide an invaluable opportunity to further the prevention science knowledge base for implementing and delivering PA programs. Despite recommendations that screening is important to increase patient safety, the specific screening criteria best suited for different community applications are unknown. To add to the limited knowledge base, we examined the screening procedures and the occurrence of adverse events among more than 5,500 participants from 11 diverse PA interventions participating in a trans-National Institutes of Health (NIH) collaborative known as the Behavior Change Consortium (BCC). Numerous adverse events occur in sedentary, chronically ill, or older populations, although few are attributed to activity/exercise interventions. No serious study-related adverse events (SRAEs) were reported across different screening practices, interventions, and/or populations. Relatively few minor SRAEs were reported (primarily musculoskeletal injuries), emphasizing the need to be aware of potential musculoskeletal sequelae during exercise interventions. One common characteristic of these studies is that they recommended "start low and go slow" strategies, with moderate intensity PA as the goal behavior. Recommendations to reframe the meaning and use of screening criteria to initiate PA in the community are discussed. Although we were unable to conduct generalizable quantitative analyses from our data, the combined experience of the BCC studies provides a unique opportunity to examine PA-related screening and safety issues across diverse populations, settings, and intervention programs.
Prehabilitation Exercise Before Urologic Cancer Surgery: A Systematic and Interdisciplinary Review. [2022]The Consensus on Therapeutic Exercise Training (CONTENT) scale assesses the therapeutic validity of exercise programs. To date, prehabilitation exercise programs for heath optimization before urologic cancer surgeries have not been assessed for therapeutic validity or efficacy.
Physical activity pattern of patients with interstitial lung disease compared to patients with COPD: A propensity-matched study. [2023]Physical activity (PA) is reduced in patients with interstitial lung disease (ILD) and chronic obstructive pulmonary disease (COPD). Evidence about the PA pattern of patients with ILD is scarce. If PA of patients with ILD would be comparable to COPD, it is tempting to speculate that existing interventions focusing on enhancing PA could be as effective in ILD as already shown in COPD. Therefore, we aimed to compare PA and the correlates with PA in matched patients with ILD, COPD, and healthy subjects.
Short term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease. [2022]Interstitial lung disease (ILD) is characterised by exertional dyspnoea, exercise limitation and reduced quality of life. The role of exercise training in this diverse patient group is unclear. The aims of this study were to establish the safety of exercise training in ILD; its effects on exercise capacity, dyspnoea and quality of life; and whether patients with idiopathic pulmonary fibrosis (IPF) had similar responses to those with other types of ILD.
Replicability of Physical Exercise Interventions in Lung Transplant Recipients; A Systematic Review. [2020]Introduction: This systematic review aimed to assess the replicability of physical exercise interventions in lung transplantation patients. For replicability we focused on (1) the description of training principles, (2) the description of FITT components and adherence to the interventions, (3) the amount of detailed information given on the physical exercise intervention, and (4) reporting the methodological quality of the included works. Methods: Relevant databases (Medline-Ovid, EMBASE, CINAHL, PsychInfo, Cochrane Library) were searched. Author dyads selected and systematically analyzed the included studies independent from each other. A purpose developed checklist was used to assess the details of the exercise interventions and their methodological quality. Results: From the seven included manuscripts, three described resistance training, one endurance, and three combined training approaches. All manuscripts reported specificity and initial values, six manuscripts mention progression and overload. The exercise principle reversibility was reported once and diminishing returns was not reported at all. All studies reported the type of exercise, three studies reported intensity and one study reported time for training. Not any study completely reported frequency or described adherence to the intervention. Lack of detailed reporting was identified as the cause for murky description of the interventions. The highest score for intervention description was 5 of possible 12 items. Conclusions: Replicability of many exercise interventions in LTX is not warranted due too poor descriptions of important items related to training. In particular there were insufficiently detailed reporting of training principles and FITT components in programs developed for LTX. Future interventions that aim to train LTX patients should spent effort in writing reports in which the intervention is detailed to such an extent that full replicability in clinical settings can be guaranteed.
Exercise stress test interpretation for cardiac diagnosis and functional evaluation. [2008]The physiatrist, with the assistance of the physical therapist, can be the appropriate individual to prescribe and supervise exercise training programs for cardiac patients, although exercise testing is probably best left to cardiologists. Exercise test data, as supplied by the cardiologist from a diagnostic test, are often not sufficient for exercise programming - since diagnostic and fitness type testing may be carried out on different modalities, with monitoring of different parameters, using different test patterns to different endpoints, and with the patient on medication rather than off. This article describes special test modifications which provide information useful in preparing exercise guidelines for individual patients. These include walk-through, second-effort testing, testing on medication and non-standard monitoring. Based upon results from the fitness type of test, it is possible to predict which exercise candidates will benefit most from exercise programming and which should be referred elsewhere for more intensive medical management or consideration of surgery.