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Physical Activity in Hidradenitis Suppurativa (HS)

Not Applicable
Recruiting
Conditions
Hidradenitis Suppurativa
Interventions
Behavioral: Home Exercise Program
Behavioral: Short Exercise Program
Registration Number
NCT06015438
Lead Sponsor
University of Miami
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
50
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Home Exercise EP GroupHome Exercise ProgramParticipants in this group will follow an at home personalized EP for up to 12 weeks.
Short EP GroupShort Exercise ProgramParticipants in this group will be enrolled in the short EP program.
Primary Outcome Measures
NameTimeMethod
Change in Functional Strength/Endurance as Measured by 30-second chair-stand testBaseline 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.

Change in Functional Strength/Endurance as measured by six-minute walk testBaseline 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.

Change in Functional Strength as measured by hand grip strength testBaseline and up to 12 weeks

It is a measure of upper body muscular strength measured in kilograms.

Secondary Outcome Measures
NameTimeMethod
Quality of life impairment as measured by the DLQIBaseline, 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.

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

Quality of life impairment as measured by the HiSQOLBaseline, 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.

Average pain as assessed by the Numerical Rating Scale (NRS)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.

Change in Level of Activity as measured by the average number of steps dailyBaseline, up to 12 weeks

Average number of steps daily will be measured with a pedometer and will be reported.

Change in Severity of HS score using the IHS-4Baseline, 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.

Trial Locations

Locations (1)

University of Miami

🇺🇸

Miami, Florida, United States

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