Physical Activity in Hidradenitis Suppurativa (HS)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Home Exercise EP Group Participants in this group will follow an at home personalized EP for up to 12 weeks. |
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.
|
| Active Comparator: Short EP Group Participants in this group will be enrolled in the short EP program. |
Behavioral: 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 .
|
Outcome Measures
Primary Outcome Measures
- Change in Functional Strength/Endurance as Measured by 30-second chair-stand test [Baseline 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 test [Baseline 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 test [Baseline and up to 12 weeks]
It is a measure of upper body muscular strength measured in kilograms.
Secondary Outcome Measures
- Quality of life impairment as measured by the DLQI [Baseline, 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.
- Quality of life impairment as measured by the HiSQOL [Baseline, 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.
- 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
- Change in Level of Activity as measured by the average number of steps daily [Baseline, 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-4 [Baseline, 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults 18 years old to 80 years old
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Have diagnosis of HS confirmed by a dermatologist
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Able to provide informed consent
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For the extended portion of the study: Classified as having moderate-to-severe HS as per the IHS-4 criteria
Exclusion Criteria:
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Individuals who are not yet adults
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Women known to be pregnant
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Prisoners
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Subjects, who in the opinion of the PI, cannot comply with the study procedures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami | Miami | Florida | United States | 33125 |
Sponsors and Collaborators
- University of Miami
Investigators
- Principal Investigator: Hadar Lev-Tov, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20230495