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

Trial Summary

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 data supports the effectiveness of the treatment for Hidradenitis Suppurativa?

Research on home-based exercise programs for breast cancer patients shows that such programs can improve quality of life and physical function. While this is not directly related to Hidradenitis Suppurativa, it suggests that exercise programs might help improve overall well-being in patients with chronic conditions. ^{1 2 3 4 5}

Is a home exercise program generally safe for humans?

Research indicates that home-based exercise programs are generally safe for humans, as shown in studies like the one on facioscapulohumeral muscular dystrophy and the LIFTMOR trial for postmenopausal women, which found these programs to be safe and effective. ^{6 7 8 9 10}

How does the exercise program treatment for Hidradenitis Suppurativa differ from other treatments?

The exercise program for Hidradenitis Suppurativa is unique because it focuses on physical activity to manage the condition, unlike traditional treatments that may involve medication or surgery. This approach is similar to exercise programs used in other conditions, like breast cancer recovery, where exercise helps improve physical and psychological well-being. ^{3 8 11 12 13}

What is the purpose of this trial?

The purpose of the study is to characterize the challenges to physical activity and exercise for HS patients and design an exercise program (EP) with evidence-based techniques and examine its outcome.

Research Team

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Variability and limitations in home-based exercise program descriptions in oncology: a scoping review. [2020]

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

The prescription or proscription of exercise in endometrial cancer care. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. [2022]

4. United States 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. [2019]

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

The effectiveness of early rehabilitation in patients with modified radical mastectomy. [2015]

6. United States 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. [2021]

7. United States 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. [2023]

8. England 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. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Home exercise program compliance of service members in the deployed environment: an observational cohort study. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Understanding barriers to adherence to home exercise programs in patients with musculoskeletal neck pain. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Benefits of 24 versus 12 weeks of exercise and wellness programming for women undergoing treatment for breast cancer. [2018]

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

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. [2019]

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

A strength training program for postmenopausal women: a pilot study. [2013]