Supervised Exercise for Interstitial Cystitis

(IC/BPS Trial)

Overseen By Rory Ritts, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Bladder cancer, Stroke, Multiple sclerosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

10 Participants Needed

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?

Supervised exercise is generally safe for humans, with few serious adverse events reported. Minor issues like muscle injuries can occur, but starting with low intensity and gradually increasing can help minimize risks. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Research Team

Stephen Walker, PhD

Principal Investigator

Wake Forest University Health Sciences

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.

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

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

Trial Overview The 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

Group I: Exercise treatment group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

UNC Greensboro

Collaborator

Trials

1

Recruited

10+

University of North Carolina, Greensboro

Collaborator

Trials

33

Recruited

16,700+

Findings from Research

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

While there is a small overall increased risk of sudden cardiac death associated with physical exertion, it is important for physicians and patients to recognize that this risk can vary significantly among individuals.

To minimize risks during exercise, both physicians and patients should be well-informed about exercise risks, proper procedures, and self-monitoring techniques, emphasizing a gradual progression in exercise intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden cardiac death associated with exercise: the risk-benefit issue. Friedewald, VE., Spence, DW.[2019]

Out of 40 randomized controlled trials (RCTs) for rheumatoid arthritis (RA) and 25 for axial spondyloarthritis (axSpA), only 73% and 52% respectively reported information on harms, indicating a significant gap in the quality of reporting regarding adverse effects of supervised exercises.

Pain was the most commonly reported harm in both prespecified and non-prespecified outcomes, highlighting the need for better adherence to reporting guidelines like the CONSORT Harms 2022 Checklist to ensure a clearer understanding of the risks associated with exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of reporting and nature of harms in clinical trials on supervised exercise in patients with rheumatoid arthritis or axial spondyloarthritis. Teuwen, MMH., Vlieland, TPMV., van Weely, SFE., et al.[2023]

In a study involving 577 participants undergoing cancer treatment, exercise was found to be safe, with 20% of adverse events (AEs) reported by coaches and 28% by participants, mostly being minor musculoskeletal issues.

High-intensity exercise was associated with a higher likelihood of AEs compared to low-to-moderate exercise, but both forms of exercise are recommended for patients if there are no medical contraindications, as serious complications like lymphedema and PICC issues were low and not significantly different across exercise intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it safe to exercise during oncological treatment? A study of adverse events during endurance and resistance training - data from the Phys-Can study. Henriksson, A., Johansson, B., Radu, C., et al.[2021]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

A systematic review of 10 studies on prehabilitation exercise programs before urologic cancer surgery found that while these programs significantly improve cardiorespiratory fitness and quality of life, they have not yet shown a reduction in postsurgical complications or improved surgical outcomes.

Seven out of the ten studies demonstrated therapeutic validity, but most had a high risk of bias, indicating a need for more rigorous and standardized methodologies in future research to better assess the efficacy of these prehabilitation interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation Exercise Before Urologic Cancer Surgery: A Systematic and Interdisciplinary Review. Briggs, LG., Reitblat, C., Bain, PA., et al.[2022]

Patients with interstitial lung disease (ILD) and chronic obstructive pulmonary disease (COPD) take a similar number of daily steps (around 5600), but both groups are significantly less active than healthy individuals, who average over 10,000 steps.

While the overall amount of physical activity is comparable between ILD and COPD patients, the intensity of activity is lower in ILD, and the relationship between physical activity and exercise capacity is weaker in ILD, suggesting that interventions to increase physical activity may need to be tailored differently for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity pattern of patients with interstitial lung disease compared to patients with COPD: A propensity-matched study. Breuls, S., Pereira de Araujo, C., Blondeel, A., et al.[2023]

In a study of 57 patients with interstitial lung disease (ILD), including 34 with idiopathic pulmonary fibrosis (IPF), an 8-week supervised exercise training program was found to be safe, with 80% of participants completing it and no adverse events reported.

The exercise training led to significant improvements in exercise capacity (measured by the 6-minute walk distance) and reductions in dyspnoea and fatigue, but these benefits were not maintained 6 months after the program ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease. Holland, AE., Hill, CJ., Conron, M., et al.[2022]

The systematic review of seven studies on exercise interventions for lung transplantation patients revealed significant gaps in the reporting of training principles and FITT (Frequency, Intensity, Time, Type) components, which hinders the replicability of these interventions.

Only one study fully reported adherence to the exercise interventions, indicating a need for more detailed documentation in future research to ensure that exercise programs can be effectively replicated in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replicability of Physical Exercise Interventions in Lung Transplant Recipients; A Systematic Review. Knols, RH., Fischer, N., Kohlbrenner, D., et al.[2020]

Physiatrists, with the help of physical therapists, are well-suited to prescribe and supervise exercise programs for cardiac patients, while cardiologists should handle exercise testing due to the complexity of the data involved.

Special test modifications, such as walk-through and second-effort testing, can provide valuable insights for creating tailored exercise guidelines, helping to identify which patients will benefit most from exercise and which may need more intensive medical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise stress test interpretation for cardiac diagnosis and functional evaluation. Zohman, LR.[2008]

References

1. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Sudden cardiac death associated with exercise: the risk-benefit issue. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Quality of reporting and nature of harms in clinical trials on supervised exercise in patients with rheumatoid arthritis or axial spondyloarthritis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Prehabilitation Exercise Before Urologic Cancer Surgery: A Systematic and Interdisciplinary Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Physical activity pattern of patients with interstitial lung disease compared to patients with COPD: A propensity-matched study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Short term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Replicability of Physical Exercise Interventions in Lung Transplant Recipients; A Systematic Review. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Exercise stress test interpretation for cardiac diagnosis and functional evaluation. [2008]