Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT06111118
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Sustained Heat Treatment on Delayed-Onset Muscle Soreness (DOMS)
Sponsor:
Aziende Chimiche Riunite Angelini Francesco S.p.A
Organization:
Study Overview
Official Title:
The Effectiveness of Sustained Heat Treatment on Delayed-Onset Muscle Soreness (DOMS) - An International, Multicenter, Open-label, Randomized Investigation
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOMS
Brief Summary:
This post-market clinical follow-up, open-label, multicenter, randomized, parallel group clinical investigation is designed to investigate the effectiveness, safety, and tolerability of immediate and delayed ThermaCare HeatWraps (medical device) applications against no treatment.
Detailed Description:
This post-market clinical follow-up, open-label, multicenter, randomized, parallel group clinical investigation is designed to investigate the effectiveness, safety, and tolerability of immediate and delayed ThermaCare HeatWraps applications against no treatment.
Approximately 100 subjects, aged between 18 and 55 years (inclusive), will be enrolled into the investigation.
Having given informed consent and personal data processing consent, subjects will undergo a medical screening on Day 1 (Visit 1) to confirm their eligibility to enter the investigation.
Subjects who are qualified to enter the investigation will be randomized in a 2:2:1 ratio to one of the following 3 treatment groups, respectively:
* Group 1: Immediate ThermaCare HeatWraps application (approximately 40 subjects)
* Group 2: Delayed ThermaCare HeatWraps application (starting 24 hours after exercise; approximately 40 subjects)
* Group 3: No treatment (approximately 20 subjects) To induce DOMS, the subjects randomized into the investigation will perform a standardized exercise routine of squats between 14:00 and 15:00. An exercise monitor will set the pace at 3 seconds per squat, and subjects will be instructed to flex the hip past 110 degrees. Each set will last for 5 minutes followed by a 3-minute rest, which will be repeated two more times, for a total of 3 sets.
Approximately 100 subjects, aged between 18 and 55 years (inclusive), will be enrolled into the investigation.
Having given informed consent and personal data processing consent, subjects will undergo a medical screening on Day 1 (Visit 1) to confirm their eligibility to enter the investigation.
Subjects who are qualified to enter the investigation will be randomized in a 2:2:1 ratio to one of the following 3 treatment groups, respectively:
* Group 1: Immediate ThermaCare HeatWraps application (approximately 40 subjects)
* Group 2: Delayed ThermaCare HeatWraps application (starting 24 hours after exercise; approximately 40 subjects)
* Group 3: No treatment (approximately 20 subjects) To induce DOMS, the subjects randomized into the investigation will perform a standardized exercise routine of squats between 14:00 and 15:00. An exercise monitor will set the pace at 3 seconds per squat, and subjects will be instructed to flex the hip past 110 degrees. Each set will last for 5 minutes followed by a 3-minute rest, which will be repeated two more times, for a total of 3 sets.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: