- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06815640
Effects of Intermittent Pneumatic Compression on Recovery of Cyclists
July 29, 2025 updated by: Filipe Silvano Pinto Maia, University of Maia
Effects of Intermittent Pneumatic Compression on the Recovery of High-level Cyclists
This study aims to assess the recovery kinetics of road cyclists following a fatigue protocol (30 time trial).
Study Overview
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Maia, Portugal
- Universidade da Maia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Road cyclists competing nationally
Exclusion Criteria:
- Injured athletes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IPC
Intermittent pneumatic compression treatment (30 min peristaltic protocol, at 200mmHg)
|
Fatigue protocol
|
|
Placebo Comparator: Placebo
A hydrant cream will be used as a placebo
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Fatigue protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle soreness
Time Frame: Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
Muscle soreness will be assessed using the likert scale of muscle soreness (ranging from 0 to 6)
|
Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
|
Creatine Kinase
Time Frame: Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
Creatine kinase will be assessed
|
Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Low frequency fatigue - Myocece Powerdex score
Time Frame: Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
Low frequency fatigue will be assessed using Myocene
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Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
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4 min time trial
Time Frame: 24 hours post intervention
|
A 4 minute time trial will be conducted at the 24th hour post-intervention.
|
24 hours post intervention
|
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Isometric knee extension srength
Time Frame: Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
Isometric Knee extension exercise will be assessed
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Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
|
Percieved fatigue
Time Frame: Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
Likert scale of percieved fatigue (ranging from 0 to 10)
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Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
|
Sleep questionnaires (consensus sleep diary)
Time Frame: Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
Sleep quality and quantity will be assessed using a questionnaire, based on the consensus sleep diary
|
Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
|
Perceived recovery
Time Frame: Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
Total quality recovery scale will be used
|
Baseline, post 30 minutes, post 24 hours, and post 48 hours
|
|
Nutritional diaries
Time Frame: Baseline, post 24 hours, and post 48 hours
|
Participants will be asked about their nutritional intake during the timecourse of the assessments
|
Baseline, post 24 hours, and post 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2025
Primary Completion (Actual)
April 15, 2025
Study Completion (Actual)
July 12, 2025
Study Registration Dates
First Submitted
January 12, 2025
First Submitted That Met QC Criteria
February 3, 2025
First Posted (Actual)
February 7, 2025
Study Record Updates
Last Update Posted (Actual)
July 30, 2025
Last Update Submitted That Met QC Criteria
July 29, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PDFM_005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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