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

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 Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Behavioral: Home Exercise Program; Behavioral: Short Exercise Program

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadar V Lev-Tov, MD; Phone Number: 3052431953; Email: hlevtov@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • Recruiting
      • University of Miami
      • Contact: Maria V Muniz; Phone Number: 305-689-2646; Email: mmuniz@med.miami.edu
      • Principal Investigator: Hadar Lev-Tov, MD
      • Contact: Leigh Nattkemper, MD; Phone Number: 3055889734; Email: lxn202@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Hadar Lev-Tov, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: 20230495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No