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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control group
Behavioral: MICT + CPT, HIIT + CPT, SIT + CPT
Single acute intervention, each exercise mode had a washout period of at least 7 days.
Experimental: sleep disorder group
Behavioral: MICT + CPT, HIIT + CPT, SIT + CPT
Single acute intervention, each exercise mode had a washout period of at least 7 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Sport University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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