Back to resultsPhysical Activity in Hidradenitis Suppurativa (HS)
Primary Purpose
Hidradenitis Suppurativa
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Exercise Program
Short Exercise Program
Sponsored by
About this trial
This is an interventional supportive care trial for Hidradenitis Suppurativa
Eligibility Criteria
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
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home Exercise EP Group
Short EP Group
Arm Description
Participants in this group will follow an at home personalized EP for up to 12 weeks.
Participants in this group will be enrolled in the short EP program.
Outcomes
Primary Outcome Measures
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.
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.
Change in Functional Strength as measured by hand grip strength test
It is a measure of upper body muscular strength measured in kilograms.
Secondary Outcome Measures
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.
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.
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
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06015438
Brief Title
Physical Activity in Hidradenitis Suppurativa (HS)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home Exercise EP Group
Arm Type
Experimental
Arm Description
Participants in this group will follow an at home personalized EP for up to 12 weeks.
Arm Title
Short EP Group
Arm Type
Active Comparator
Arm Description
Participants in this group will be enrolled in the short EP program.
Intervention Type
Behavioral
Intervention Name(s)
Home Exercise Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Short Exercise Program
Intervention Description
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 Outcome Measure Information:
Title
Change in Functional Strength/Endurance as Measured by 30-second chair-stand test
Description
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.
Time Frame
Baseline and up to 12 weeks
Title
Change in Functional Strength/Endurance as measured by six-minute walk test
Description
Six-minute walk measures overall functioning capacity, and lower body muscle strength/ endurance, with a composite score reported in meters.
Time Frame
Baseline and up to 12 weeks
Title
Change in Functional Strength as measured by hand grip strength test
Description
It is a measure of upper body muscular strength measured in kilograms.
Time Frame
Baseline and up to 12 weeks
Secondary Outcome Measure Information:
Title
Quality of life impairment as measured by the DLQI
Description
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.
Time Frame
Baseline, up to 12 weeks
Title
Quality of life impairment as measured by the HiSQOL
Description
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.
Time Frame
Baseline, up to 12 weeks
Title
Change in Physical activity as measured by the International Physical Activity Questionnaire (IPAQ)
Description
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
Time Frame
Baseline, up to 12 weeks
Title
Change in Level of Activity as measured by the average number of steps daily
Description
Average number of steps daily will be measured with a pedometer and will be reported.
Time Frame
Baseline, up to 12 weeks
Title
Change in Severity of HS score using the IHS-4
Description
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.
Time Frame
Baseline, up to 12 weeks
Title
Average pain as assessed by the Numerical Rating Scale (NRS)
Description
The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
Time Frame
Up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadar V Lev-Tov, MD
Phone
3052431953
Email
hlevtov@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria V Muniz
Phone
305-689-2646
Email
mmuniz@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Leigh Nattkemper, MD
Phone
3055889734
Email
lxn202@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physical Activity in Hidradenitis Suppurativa (HS)
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