Physical Activity in Hidradenitis Suppurativa (HS)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Behavioral: Home Exercise Program
* Behavioral: Short Exercise Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Exercise EP Group<br>Participants in this group will follow an at home personalized EP for up to 12 weeks. | Behavioral: Home Exercise Program<br>* 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.<br>|
| Active Comparator: Short EP Group<br>Participants in this group will be enrolled in the short EP program. | Behavioral: Short Exercise Program<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | 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. | 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. | Up to 8 weeks |