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Physical Activity in Hidradenitis Suppurativa (HS)

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06015438
Enrollment
86
Registered
2023-08-29
Start date
2023-06-07
Completion date
2025-11-25
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa

Brief 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.

Interventions

BEHAVIORALHome 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.

BEHAVIORALShort 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 .

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Functional Strength/Endurance as Measured by 30-second chair-stand testBaseline and up to 12 weeksDetermines 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 testBaseline and up to 12 weeksSix-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 testBaseline and up to 12 weeksIt is a measure of upper body muscular strength measured in kilograms.

Secondary

MeasureTime frameDescription
Quality of life impairment as measured by the DLQIBaseline, up to 12 weeksDermatology Life Quality Index (DLQI) has a total score ranging from 0 to 30 with the lower score indicating higher health related quality of life.
Quality of life impairment as measured by the HiSQOLBaseline, up to 12 weeksHidradenitis 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.
Change in Physical activity as measured by the International Physical Activity Questionnaire (IPAQ)Baseline, up to 12 weeksIPAQ 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
Change in Level of Activity as measured by the average number of steps dailyBaseline, up to 12 weeksAverage number of steps daily will be measured with a pedometer and will be reported.
Change in Severity of HS score using the IHS-4Baseline, up to 12 weeksThe International Hidradenitis Suppurativa Severity Score System (IHS4) measures HS severity as mild (0-3), moderate (4-10), severe (≥11). Higher score indicate increased severity.
Average pain as assessed by the Numerical Rating Scale (NRS)Up to 8 weeksThe average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHadar Lev-Tov, MD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026