Physical Activity in Hidradenitis Suppurativa (HS)

NCT06015438 | Active Not Recruiting

• 1 other identifier: 20230495
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and up to 12 weeks

Secondary Outcomes (6)

• Quality of life impairment as measured by the DLQI

  Baseline, up to 12 weeks

• Quality of life impairment as measured by the HiSQOL

  Baseline, up to 12 weeks

• Change in Physical activity as measured by the International Physical Activity Questionnaire (IPAQ)

  Baseline, up to 12 weeks

• Change in Level of Activity as measured by the average number of steps daily

  Baseline, up to 12 weeks

• Change in Severity of HS score using the IHS-4

  Baseline, up to 12 weeks

Study Arms (2)

Home Exercise EP Group

EXPERIMENTAL

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

Behavioral: Home Exercise Program

Short EP Group

ACTIVE COMPARATOR

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

Behavioral: Short Exercise Program

Interventions

Home Exercise Program BEHAVIORAL

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.

Home Exercise EP Group

Short Exercise Program BEHAVIORAL

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 .

Short EP Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33125, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Hadar Lev-Tov, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: June 7, 2023
• Primary Completion: January 27, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)