Sleep QualityNCT06483633
Effects of Combining Different Exercise Modes With CPT on Vascular Function and Sleep Quality in Female University Students With SD
A study testing MICT + CPT, HIIT + CPT, SIT + CPT in people with Sleep Quality and Vascular Function, run by Beijing Sport University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Vascular Function
- What is being tested?
- MICT + CPT, HIIT + CPT, SIT + CPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
School of Sports Medicine and Rehabilitation, Beijing Sport University
Beijing
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Quality, Vascular Function
- Being tested
- MICT + CPT, HIIT + CPT, SIT + CPT
- Keywords
- exercise, sleep disorders, cold pressor test, vascular function
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Motor Activity, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICT + CPT, HIIT + CPT, SIT + CPTBehavioural
Single acute intervention, each exercise mode had a washout period of at least 7 days.
| Study group | Role | What they receive |
|---|---|---|
| sleep disorder group | Experimental | Not described Receives: Behavioral: MICT + CPT, HIIT + CPT, SIT + CPT |
| Control group | Experimental | Not described Receives: Behavioral: MICT + CPT, HIIT + CPT, SIT + CPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
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.
Measured: The next morning following each intervention, within 24 hours post-intervention
Ankle-brachial pulse wave velocity (baPWV)
The change of baPWV before and after intervention.
Measured: Immediately after each intervention and 30 minutes later.
Ankle-brachial index (ABI)
The change of ABI before and after intervention.
Measured: Immediately after each intervention and 30 minutes later.
Secondary outcomes (1)
Blood pressure
The change of blood pressure before and after intervention.
Measured: Immediately after each intervention and 30 minutes later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Aug 2022
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483633
- Sponsor's protocol ID
- EOCDEMWCPTOVFASQIFUSWSD
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combining Different Exercise Modes With Cold Pressor Test on Vascular Function and Sleep Quality in Female University Students With Sleep Disorders
- ClinicalTrials.gov ID
- NCT06483633
- Acronym / sponsor ID
- EOCDEMWCPTOVFASQIFUSWSD
- Conditions
- Sleep Quality, Vascular Function
- Keywords
- exercise, sleep disorders, cold pressor test, vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sleep disorder group | Experimental | Behavioral: MICT + CPT, HIIT + CPT, SIT + CPT |
| Control group | Experimental | Behavioral: MICT + CPT, HIIT + CPT, SIT + CPT |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MICT + CPT, HIIT + CPT, SIT + CPTSingle acute intervention, each exercise mode had a washout period of at least 7 days. | Behavioural | Control group, sleep disorder group |
Primary outcome
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.
Ankle-brachial pulse wave velocity (baPWV)
Time frame: Immediately after each intervention and 30 minutes later.
The change of baPWV before and after intervention.
Ankle-brachial index (ABI)
Time frame: Immediately after each intervention and 30 minutes later.
The change of ABI before and after intervention.
1 secondary outcome
Blood pressure
Time frame: Immediately after each intervention and 30 minutes later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MICT + CPT, HIIT + CPT, SIT + CPT in people with Sleep Quality and Vascular Function, run by Beijing Sport University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: The next morning following each intervention, within 24 hours post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024; AzTrials last refreshed its copy on 2 Nov 2026.