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Exercise Programs for Hidradenitis Suppurativa
N/A
Recruiting
Led By Hadar Lev-Tov, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have diagnosis of HS confirmed by a dermatologist
For the extended portion of the study: Classified as having moderate-to-severe HS as per the IHS-4 criteria
Must not have
Individuals who are not yet adults
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to design an exercise program for HS patients to help them better cope with physical activity difficulties.
Who is the study for?
This trial is for adults aged 18-80 with Hidradenitis Suppurativa (HS) confirmed by a dermatologist. Participants must be able to consent and, for part of the study, have moderate-to-severe HS as per IHS-4 criteria. Pregnant women, minors, prisoners, or those unable to follow the study procedures are excluded.
What is being tested?
The trial aims to understand physical activity challenges in HS patients and test an exercise program designed using evidence-based techniques. The effectiveness of this home-based short exercise regimen on HS will be evaluated.
What are the potential side effects?
Since this trial involves a physical activity program rather than medication, side effects may include typical exercise-related issues such as muscle soreness or strain but should generally be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
A dermatologist has confirmed I have HS.
Select...
My HS condition is classified as moderate-to-severe.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under the age of 18.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Functional Strength as measured by hand grip strength test
Change in Functional Strength/Endurance as Measured by 30-second chair-stand test
Change in Functional Strength/Endurance as measured by six-minute walk test
Secondary study objectives
Average pain as assessed by the Numerical Rating Scale (NRS)
Change in Level of Activity as measured by the average number of steps daily
Change in Physical activity as measured by the International Physical Activity Questionnaire (IPAQ)
+3 moreSide effects data
From 2012 Phase 3 trial • 408 Patients • NCT0024391955%
Minor fall, no or minimal injury
32%
Hospitalization
30%
Other
8%
Dizziness/Fainting
6%
Low blood pressure during exercise that requires intervention to be stopped for the day
6%
Fracture
6%
Open sore or blister, cuts
5%
Muscle soreness or pain that persists for more than 48 hours
4%
Recurrent Stroke
4%
Excessive hypertension during exercise that requires the intervention to be stopped for the day
2%
Death
1%
Limitation in activities of daily living (ADL)>48hrs
1%
Diaphoretic
1%
Dyspnea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Early Locomotor Training Program
Late Locomotor Training Program
Home Exercise Program
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home Exercise EP GroupExperimental Treatment1 Intervention
Participants in this group will follow an at home personalized EP for up to 12 weeks.
Group II: Short EP GroupActive Control1 Intervention
Participants in this group will be enrolled in the short EP program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home Exercise Program
2019
Completed Phase 3
~810
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
949 Previous Clinical Trials
428,407 Total Patients Enrolled
4 Trials studying Hidradenitis Suppurativa
85 Patients Enrolled for Hidradenitis Suppurativa
Hadar Lev-Tov, MDPrincipal InvestigatorUniversity of Miami
8 Previous Clinical Trials
180 Total Patients Enrolled
4 Trials studying Hidradenitis Suppurativa
85 Patients Enrolled for Hidradenitis Suppurativa
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