Physical Activity in Hidradenitis Suppurativa (HS)

Hidradenitis Suppurativa Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015438
• Other study ID #: 20230495
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: Hadar V Lev-Tov, MD
• Phone: 3052431953
• Email: hlevtov[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

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.
• 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 .

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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