Hidradenitis SuppurativaNCT06015438
Physical Activity in Hidradenitis Suppurativa (HS)
A study testing Home Exercise Program and Short Exercise Program in people with Hidradenitis Suppurativa, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Home Exercise Program and Short Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2023to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Home Exercise Program, Short Exercise Program
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise ProgramBehavioural
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.
Short Exercise ProgramBehavioural
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 .
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise EP Group | Experimental | Participants in this group will follow an at home personalized EP for up to 12 weeks. Receives: Behavioral: Home Exercise Program |
| Short EP Group | Active comparator | Participants in this group will be enrolled in the short EP program. Receives: Behavioral: Short Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Strength/Endurance as Measured by 30-second chair-stand test
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.
Measured: Baseline and up to 12 weeks
Change in Functional Strength/Endurance as measured by six-minute walk test
Six-minute walk measures overall functioning capacity, and lower body muscle strength/ endurance, with a composite score reported in meters.
Measured: Baseline and up to 12 weeks
Change in Functional Strength as measured by hand grip strength test
It is a measure of upper body muscular strength measured in kilograms.
Measured: Baseline and up to 12 weeks
Secondary outcomes (6)
Quality of life impairment as measured by the DLQI
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.
Measured: Baseline, up to 12 weeks
Quality of life impairment as measured by the HiSQOL
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.
Measured: Baseline, up to 12 weeks
Change in Physical activity as measured by the International Physical Activity Questionnaire (IPAQ)
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
Measured: Baseline, up to 12 weeks
Change in Level of Activity as measured by the average number of steps daily
Average number of steps daily will be measured with a pedometer and will be reported.
Measured: Baseline, up to 12 weeks
Change in Severity of HS score using the IHS-4
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.
Measured: Baseline, up to 12 weeks
Average pain as assessed by the Numerical Rating Scale (NRS)
The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start7 Jun 2023
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadar Lev-Tov, University of Miami
- Investigators
- Hadar Lev-Tov, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015438
- Sponsor's protocol ID
- 20230495
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06015438
- Acronym / sponsor ID
- 20230495
- Conditions
- Hidradenitis Suppurativa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Exercise EP Group | Experimental | Behavioral: Home Exercise ProgramParticipants in this group will follow an at home personalized EP for up to 12 weeks. |
| Short EP Group | Active comparator | Behavioral: Short Exercise ProgramParticipants in this group will be enrolled in the short EP program. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Exercise ProgramParticipants 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. | Behavioural | Home Exercise EP Group |
| Short Exercise ProgramParticipants 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 . | Behavioural | Short EP Group |
Primary outcome
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.
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.
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.
6 secondary outcomes
Quality of life impairment as measured by the DLQI
Time frame: Baseline, up to 12 weeks
Quality of life impairment as measured by the HiSQOL
Time frame: 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
Change in Level of Activity as measured by the average number of steps daily
Time frame: Baseline, up to 12 weeks
Change in Severity of HS score using the IHS-4
Time frame: Baseline, up to 12 weeks
Average pain as assessed by the Numerical Rating Scale (NRS)
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadar Lev-Tov, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise Program and Short Exercise Program in people with Hidradenitis Suppurativa, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Strength/Endurance as Measured by 30-second chair-stand test (time frame: Baseline and up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 5 Nov 2026.