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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to 12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

A dermatologist has confirmed I have HS.

Select...

My HS condition is classified as moderate-to-severe.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 more

Side effects data

From 2012 Phase 3 trial • 408 Patients • NCT00243919

55%

Minor fall, no or minimal injury

32%

Hospitalization

30%

Other

Dizziness/Fainting

Open sore or blister, cuts

Fracture

Low blood pressure during exercise that requires intervention to be stopped for the day

Muscle soreness or pain that persists for more than 48 hours

Recurrent Stroke

Excessive hypertension during exercise that requires the intervention to be stopped for the day

Death

Limitation in activities of daily living (ADL)>48hrs

Dyspnea

Diaphoretic

100%

80%

60%

40%

20%

Study treatment Arm

Early Locomotor Training Program

Late Locomotor Training Program

Home Exercise Program

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

~760

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

410,026 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment accept participants of aged fifty or older?

"This trial is open to those 18-80 years old. Additionally, 4 studies are available for youths under the age of consent and 35 trials specifically target seniors over 65."

Answered by AI

Who is eligible for participation in this clinical research?

"In order to qualify for this clinical trial, individuals must suffer from hidradenitis suppurativa and be between 18-80 years of age. The team is seeking a cohort of 50 participants in total."

Answered by AI

Are enrollees still being accepted into this experiment?

"Unfortunately, this clinical trial as listed on clinicaltrials.gov is no longer recruiting participants; the original post went live November 1st 2023 and was last edited August 23rd, 2023. Nonetheless, 39 other trials are actively enrolling at present."

Answered by AI

What results are expected from this experiment?

"The primary efficacy endpoint of this clinical trial will be evaluated over Baseline and up to 12 weeks, focusing on changes in functional strength/endurance as measured by six-minute walk tests. Secondary objectives include the International Physical Activity Questionnaire (IPAQ), which assesses 3 types of physical activity taken across 4 domains for the last 7 days; an average number of steps daily recorded with a pedometer; and the IHS-4 score system measuring HS severity from mild to severe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Physical Activity in Hidradenitis Suppurativa (HS)

Hadar Lev-Tov 2023. "Physical Activity in Hidradenitis Suppurativa (HS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06015438.

All > Hidradenitis Suppurativa