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NCT Number: NCT06015438

Physical Activity in Hidradenitis Suppurativa (HS)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33125, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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 .

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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