- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06483633
Effects of Combining Different Exercise Modes With CPT on Vascular Function and Sleep Quality in Female University Students With SD
July 1, 2024 updated by: Beijing Sport University
Effects of Combining Different Exercise Modes With Cold Pressor Test on Vascular Function and Sleep Quality in Female University Students With Sleep Disorders
Fourteen female college students with sleep disorders (SD) and fourteen with good sleep status were recruited, divided into sleep disorder group (SDG) and control group (CG).
Both groups underwent moderate-intensity continuous training (MICT), high-intensity interval training (HIIT), and sprint interval training (SIT).
Immediately after exercise, Cold Pressor Test (CPT) was administered, vascular indicators were measured immediately and 30 minutes later.
The next day after exercise, participants completed the Pittsburgh sleep quality index (PSQI).
Each exercise mode had a washout period of at least 7 days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Both SDG and CG underwent HIIT, MICT, and SIT interventions.
After the exercise, a CPT was conducted, and vascular indicators were immediately measured at the end of the intervention.
Another measurement was taken 30 minutes after the intervention.
The exercise was performed on a power bike, with the requirement to maintain a pedaling frequency of 60 rpm.
The exercise protocols for HIIT, MICT, and SIT were designed with equal exercise volume.
The HIIT protocol consisted of 4 sets of 4 minutes at 85% maximal oxygen uptake data (VO2max), interspersed with 3 minutes at 50% VO2max.
The MICT protocol involved continuous pedaling at 60% VO2max for 32 minutes.
The SIT protocol included 6 sets of 30-second all-out sprints (100% VO2max) with 4.5 minutes of recovery at 60% VO2max between each sprint.
There was a minimum of 7 days between each exercise mode as a washout period.
The PSQI questionnaire was completed the day after each intervention upon waking up.
Study Type
Interventional
Enrollment (Actual)
28
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
-
-
-
Beijing, China
- School of Sports Medicine and Rehabilitation, Beijing Sport University
-
-
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:
- Female university students aged between 18 and 30 years old
- Body Mass Index (BMI) between 18.5~24.0 kg/m2
- Presence of SD (PSQI > 8 points) or good sleep quality (PSQI ≤ 7 points)
- Not taking medications that affect sleep
- No cardiovascular diseases
- No regular exercise habits or specialized training but possessing the ability to complete the exercise program
Exclusion Criteria:
- Severe organic diseases such as heart, kidney, etc
- Metabolic diseases such as diabetes, etc.
- Taking medications that affect sleep (including drugs that promote or interfere with sleep)
- Permanent and severe exercise dysfunction
- Participation in other experiments
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: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control group
|
Single acute intervention, each exercise mode had a washout period of at least 7 days.
|
|
Experimental: sleep disorder group
|
Single acute intervention, each exercise mode had a washout period of at least 7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Time Frame: The next morning following each intervention, within 24 hours post-intervention
|
The change of Pittsburgh Sleep Quality Index (PSQI) before and after the intervention, Pittsburgh Sleep Quality Index include: specifically PSQI total score, sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, and daytime functioning.
|
The next morning following each intervention, within 24 hours post-intervention
|
|
Ankle-brachial pulse wave velocity (baPWV)
Time Frame: Immediately after each intervention and 30 minutes later.
|
The change of baPWV before and after intervention.
|
Immediately after each intervention and 30 minutes later.
|
|
Ankle-brachial index (ABI)
Time Frame: Immediately after each intervention and 30 minutes later.
|
The change of ABI before and after intervention.
|
Immediately after each intervention and 30 minutes later.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: Immediately after each intervention and 30 minutes later.
|
The change of blood pressure before and after intervention.
|
Immediately after each intervention and 30 minutes later.
|
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)
August 1, 2022
Primary Completion (Actual)
November 30, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
June 23, 2024
First Submitted That Met QC Criteria
July 1, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 1, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EOCDEMWCPTOVFASQIFUSWSD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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