Exercise Programs for Hidradenitis Suppurativa

Overseen By Hadar V Lev-Tov, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnancy, Prisoners, Non-compliance, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to design and test exercise programs for people with hidradenitis suppurativa (HS), a skin condition that causes painful lumps. Researchers seek to understand the challenges HS patients face with physical activity and explore how exercise can help. Participants will follow either a personalized home exercise program for up to 12 weeks or a shorter exercise program. The trial seeks individuals diagnosed with moderate-to-severe HS by a dermatologist. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance exercise recommendations for HS patients.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these exercise programs are safe for HS patients?

Research shows that home-based exercise programs are generally safe. These programs have been tested in other conditions, such as a type of muscular dystrophy, and have been well-received. For individuals with hidradenitis suppurativa (HS), the main concerns with exercise are sweating and pain. While sweating is a normal part of exercising, it can be uncomfortable for those with HS. However, these exercise programs have not revealed any serious safety issues. Participants in similar studies successfully managed these concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise programs being studied for hidradenitis suppurativa because they're exploring a non-drug approach to manage this challenging skin condition. Most current treatments focus on medications like antibiotics, biologics, or surgery to reduce inflammation and manage symptoms. However, these exercise programs aim to improve patients' quality of life through physical activity, potentially reducing flare-ups and pain. The Home Exercise Program offers a personalized routine that participants can follow at home for up to 12 weeks, providing flexibility and convenience. The Short Exercise Program serves as a comparator, allowing researchers to evaluate the effectiveness of different exercise durations and intensities.

What evidence suggests that these exercise programs could be effective for Hidradenitis Suppurativa?

This trial will compare two exercise programs for managing symptoms of hidradenitis suppurativa (HS), a long-term skin condition. Participants in one arm will follow a Home Exercise Program, a personalized plan designed to be safe and effective for people with HS. Another arm will involve a Short Exercise Program. Research has shown that exercise can improve skin health by reducing inflammation and enhancing overall well-being. However, some people find exercise difficult due to sweating and pain, so personalized exercise plans that address these challenges can be beneficial. Regular physical activity has also been proven to help with chronic pain, which is common for those with HS. ^{1 2 3 6 7}

Who Is on the Research Team?

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with Hidradenitis Suppurativa (HS) confirmed by a dermatologist. Participants must be able to consent and, for part of the study, have moderate-to-severe HS as per IHS-4 criteria. Pregnant women, minors, prisoners, or those unable to follow the study procedures are excluded.

Inclusion Criteria

Able to provide informed consent

A dermatologist has confirmed I have HS.

My HS condition is classified as moderate-to-severe.

Exclusion Criteria

Women known to be pregnant

Prisoners

Subjects, who in the opinion of the PI, cannot comply with the study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow an at-home personalized exercise program for up to 12 weeks

12 weeks

Baseline assessment and periodic virtual check-ins

Follow-up

Participants are monitored for changes in functional strength, physical activity, and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home Exercise Program
• Short Exercise Program

Trial Overview

The trial aims to understand physical activity challenges in HS patients and test an exercise program designed using evidence-based techniques. The effectiveness of this home-based short exercise regimen on HS will be evaluated.

How Is the Trial Designed?

Group I: Home Exercise EP Group Experimental Treatment 1 Intervention

Participants in this group will follow an at home personalized EP for up to 12 weeks.

Group II: Short EP Group Active Control 1 Intervention

Participants in this group will be enrolled in the short EP program.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

A home-based exercise program for 32 female postmastectomy patients over 8 weeks significantly reduced arm circumference and volume by approximately 122 mL, indicating effective management of lymphedema.

Participants also experienced a notable improvement in their quality of life, as measured by the 36-Item Short Form Health Survey, highlighting the program's overall benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of home-based exercise program on lymphedema and quality of life in female postmastectomy patients: pre-post intervention study. Gautam, AP., Maiya, AG., Vidyasagar, MS.[2019]

A study involving 57 women who underwent modified radical mastectomy showed that an early onset rehabilitation program significantly improved shoulder mobility and functional status compared to a home exercise program.

Both groups had similar rates of lymphedema and postoperative complications, indicating that the rehabilitation program is safe and does not increase the risk of adverse effects after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of early rehabilitation in patients with modified radical mastectomy. Cinar, N., Seckin, U., Keskin, D., et al.[2015]

A review of 229 articles revealed that 'home-based exercise' can refer to a variety of settings, including at-home, outdoors, or in community facilities, highlighting the need for clearer definitions in research.

Support for home-based exercise interventions varies widely, with elements such as supervision, printed materials, equipment, and technology being used, suggesting that tailored approaches may enhance the effectiveness of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability and limitations in home-based exercise program descriptions in oncology: a scoping review. Lopez, C., McGarragle, K., Pritlove, C., et al.[2020]

The Breast Cancer Patients Engaging in Activity and Undergoing Treatment (BEAUTY) program is a 12-week evidence-based exercise initiative designed to improve the physical and psychological well-being of women undergoing chemotherapy or radiation for breast cancer, offered at no cost to participants.

The program aims to bridge the gap between research on the benefits of exercise for breast cancer recovery and practical community implementation, ensuring safety and adherence while enhancing quality of life for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. Leach, HJ., Danyluk, JM., Culos-Reed, SN.[2022]

In a study of 155 Service Members undergoing physical therapy in Iraq and Afghanistan, it was found that those prescribed 4 or more home exercises had a lower compliance rate compared to those with 2 or fewer exercises, indicating that fewer exercises may lead to better adherence.

Additionally, Service Members who left the base at least once a week also showed lower compliance rates, suggesting that external factors may impact their ability to follow through with prescribed exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home exercise program compliance of service members in the deployed environment: an observational cohort study. Eckard, T., Lopez, J., Kaus, A., et al.[2022]

Only 14.2% of endometrial cancer patients were found to be suitable for unsupervised exercise programs based on their health status at diagnosis, which increased to 20.5% when excluding common comorbidities like hypertension and diabetes.

The study indicates that a significant majority (approximately 80%) of endometrial cancer patients may require referral to medically-supervised exercise programs due to health issues that could hinder their ability to safely engage in unsupervised exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prescription or proscription of exercise in endometrial cancer care. Zhang, X., Haggerty, AF., Brown, JC., et al.[2018]

The BEAUTY program, a community exercise initiative for breast cancer survivors, showed significant improvements in physical fitness and psychosocial outcomes after 24 weeks, including better waist-to-hip ratio, treadmill performance, and VO2max.

Participants experienced reduced fatigue, improved quality of life, and fewer depressive symptoms at 24 weeks compared to both baseline and 12 weeks, indicating that longer exercise durations may be more beneficial for recovery during and after cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of 24 versus 12 weeks of exercise and wellness programming for women undergoing treatment for breast cancer. Leach, HJ., Danyluk, JM., Nishimura, KC., et al.[2018]

The HEALTh program, a customized cardiac rehabilitation model for female breast cancer survivors, significantly improved cardiorespiratory fitness by 14% and enhanced quality of life and reduced depressive symptoms after 22 sessions.

With a program adherence rate of 66.6%, the study involved 152 breast cancer survivors, demonstrating that structured exercise and education can effectively support physical and mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. Dolan, LB., Barry, D., Petrella, T., et al.[2019]

The pilot study involving 18 postmenopausal women showed that a specific exercise program significantly increased muscle strength, with a 21% improvement in quadriceps strength and a 14% increase in grip strength after 8 weeks of training.

The program was found to be safe and acceptable, with a positive relationship between participants' adherence to the exercise regimen and their strength gains, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A strength training program for postmenopausal women: a pilot study. Heislein, DM., Harris, BA., Jette, AM.[2013]

A 6-month home-based exercise program for 16 patients with facioscapulohumeral muscular dystrophy (FSHD) resulted in significant improvements in peak oxygen uptake (VO2 peak) by 19% and enhanced muscle endurance and strength without worsening muscle condition.

The exercise program was safe, with a high compliance rate of 91%, and led to increased muscle fiber size and metabolic activity, indicating that structured exercise can provide functional benefits for FSHD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a 6-month home-based exercise program in patients with facioscapulohumeral muscular dystrophy: A randomized controlled trial. Bankolé, LC., Millet, GY., Temesi, J., et al.[2021]

Only 32% of the 292 randomized controlled trials for low back pain included a home exercise program (HEP), indicating that these programs are not commonly prescribed in supervised exercise interventions.

There was significant variability in the design and adherence monitoring of HEPs, with adherence rates reported between 29% and 82%, highlighting inconsistencies in how these programs are implemented and evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Exercise Programs Are Infrequently Prescribed in Trials of Supervised Exercise for Individuals With Low Back Pain: A Scoping Review of 292 Randomized Controlled Trials. Lee, GT., Himler, P., Rhon, DI., et al.[2023]

Adherence to home exercise programs (HEPs) is crucial for improving functional outcomes in patients with neck pain, as those who adhered to their HEPs had significantly higher functional scores at discharge compared to non-adherents (mean difference of 12.4).

Qualitative interviews with 25 patients revealed that factors such as previous physical therapy experiences, the visibility of outcomes, expectations from therapy, and pain experiences significantly influence adherence to HEPs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding barriers to adherence to home exercise programs in patients with musculoskeletal neck pain. Himler, P., Lee, GT., Rhon, DI., et al.[2023]

The LIFTMOR trial demonstrated that high-intensity progressive resistance training (HiPRT) with impact loading is safe and effective for improving bone health in postmenopausal women with low bone mass, with no reported injuries during the study.

Participants in the HiPRT group showed significant improvements in bone mineral density and functional performance compared to those in a low-intensity exercise group, indicating that high-intensity training can be beneficial for osteoporosis rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heavy resistance training is safe and improves bone, function, and stature in postmenopausal women with low to very low bone mass: novel early findings from the LIFTMOR trial. Watson, SL., Weeks, BK., Weis, LJ., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10601958/

Exercise Recommendations for Hidradenitis Suppurativa ...

Two main issues limit exercise take-up in patients with HS – sweating and pain. Sweating is the body's physiological response to exercise of sufficient ...

2.

withpower.com

withpower.com/trial/phase-hidradenitis-10-2023-82183

Exercise Programs for Hidradenitis Suppurativa

Research indicates that home-based exercise programs are generally safe for humans, as shown in studies like the one on facioscapulohumeral muscular dystrophy ...

3.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06015438/physical-activity-in-hidradenitis-suppurativa-hs

Physical Activity in Hidradenitis Suppurativa (HS)

The purpose of the study is to characterize the challenges to physical activity and exercise for HS patients and design an exercise program (EP) ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12417714/

The Effects of Physical Activity on Skin Health - PubMed Central

Physical activity may exacerbate HS symptoms due to increased perspiration and friction in these regions. Effective management of HS in the ...

5.

researchgate.net

researchgate.net/publication/373126782_Exercise_Recommendations_for_Hidradenitis_Suppurativa_Patients

(PDF) Exercise Recommendations for Hidradenitis ...

Exercise Recommendations for Hidradenitis Suppurativa Patients ; Aim for ≥2–3 days/week ; 10–30 s, to the point of feeling ; Improves range of ...

6.

trial.medpath.com

trial.medpath.com/clinical-trial/a6ec8f9892471861/nct06015438-physical-activity-hidradenitis-suppurativa

Physical Activity in Hidradenitis Suppurativa (HS) | MedPath

The purpose of the study is to characterize the challenges to physical activity and exercise for HS patients and design an exercise program (EP) ...

7.

ctv.veeva.com

ctv.veeva.com/study/physical-activity-in-hidradenitis-suppurativa-hs

Physical Activity in Hidradenitis Suppurativa (HS)

The purpose of the study is to characterize the challenges to physical activity and exercise for HS patients and design an exercise program ...