Physical Activity in Hidradenitis Suppurativa (HS)

April 27, 2026 updated by: Hadar Lev-Tov, University of Miami

Physical Activity and Hidradenitis Suppurativa: A Novel Controlled Trial Investigating Functional Performance and Activity Limitations and Assessing the Benefits of an Outcome Measures Driven Exercise Program

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33125
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 18 years old to 80 years old
  • Have diagnosis of HS confirmed by a dermatologist
  • Able to provide informed consent
  • For the extended portion of the study: Classified as having moderate-to-severe HS as per the IHS-4 criteria

Exclusion Criteria:

  • Individuals who are not yet adults
  • Women known to be pregnant
  • Prisoners
  • Subjects, who in the opinion of the PI, cannot comply with the study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home Exercise EP Group
Participants in this group will follow an at home personalized EP for up to 12 weeks.
Behavioral: Home Exercise Program
Participants will perform a minimum of one exercise from each of the targeted muscle groups at a frequency of every other day, for a total of 3-4 days a week of exercise with a rest day. The entire strengthening exercise routine should take approximately 25-30 minutes to perform, including rest periods. Each muscle grouping of exercises is designed to progress from minimal muscle effort required to moderate to maximal effort. Participants will use a video to perform the exercises as well as a handout with specific instructions.
Active Comparator: Short EP Group
Participants in this group will be enrolled in the short EP program.
Behavioral: Short Exercise Program
Participants in this group will attend one in-person visit expected to last about 60 minutes. The clinic visit will consist of standard of care procedures and tests for individuals with mild-to-severe HS .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Strength/Endurance as Measured by 30-second chair-stand test
Time Frame: Baseline and up to 12 weeks
Determines how many times a person can rise from a chair and sit down again in 30 seconds while keeping their arms crossed over their chest. The test will assess lower body strength and endurance and will be reported using a composite score of the number of times completed.
Baseline and up to 12 weeks
Change in Functional Strength/Endurance as measured by six-minute walk test
Time Frame: Baseline and up to 12 weeks
Six-minute walk measures overall functioning capacity, and lower body muscle strength/ endurance, with a composite score reported in meters.
Baseline and up to 12 weeks
Change in Functional Strength as measured by hand grip strength test
Time Frame: Baseline and up to 12 weeks
It is a measure of upper body muscular strength measured in kilograms.
Baseline and up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average pain as assessed by the Numerical Rating Scale (NRS)
Time Frame: Up to 8 weeks
The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
Up to 8 weeks
Quality of life impairment as measured by the DLQI
Time Frame: Baseline, up to 12 weeks
Dermatology Life Quality Index (DLQI) has a total score ranging from 0 to 30 with the lower score indicating higher health related quality of life.
Baseline, up to 12 weeks
Quality of life impairment as measured by the HiSQOL
Time Frame: Baseline, up to 12 weeks
Hidradenitis Suppurativa Quality of Life (HiSQOL) has a total score ranging from 0 to 68 with the lower score indicating higher health related quality of life.
Baseline, up to 12 weeks
Change in Physical activity as measured by the International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline, up to 12 weeks
IPAQ assesses 3 types of physical activity undertaken across the 4 domains- leisure time physical activity; domestic and gardening (yard) activities; work-related physical activity; transport-related physical activity- in the previous 7 days. The 3 types of activity assessed are walking, moderate-intensity activities and vigorous-intensity activities. The result s is not reported in scales. Computation of the total score for the IPAQ requires summation of the duration (in minutes) and frequency (days) of the 3 types of activities across the 4 domains. Higher result indicates higher physical activity in the last 7 days
Baseline, up to 12 weeks
Change in Level of Activity as measured by the average number of steps daily
Time Frame: Baseline, up to 12 weeks
Average number of steps daily will be measured with a pedometer and will be reported.
Baseline, up to 12 weeks
Change in Severity of HS score using the IHS-4
Time Frame: Baseline, up to 12 weeks
The International Hidradenitis Suppurativa Severity Score System (IHS4) measures HS severity as mild (0-3), moderate (4-10), severe (≥11). Higher score indicate increased severity.
Baseline, up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Hadar Lev-Tov, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2023

Primary Completion (Actual)

January 27, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230495

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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