Effects of Combining Different Exercise Modes With CPT on... | NCT06483633

Studies
Effects of Combining Different Exercise Modes With CPT on Vascular Function and Sleep Quality in Female University Students With SD

NCT06483633

Sponsor

Beijing Sport University

Status

Completed

Last Update Posted

Jul 3, 2024Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Sleep Quality
Vascular Function

Interventions

MICT + CPT, HIIT + CPT, SIT + CPT

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Actual

Primary Completion Date

Nov 30, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jun 23, 2024

First Submission Date that Met QC Criteria

Jul 1, 2024

First Posted Date

Jul 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2024

Last Update Posted Date

Jul 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 (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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sleep disorder group	Experimental		Behavioral: MICT + CPT, HIIT + CPT, SIT + CPT
Control group	Experimental		Behavioral: MICT + CPT, HIIT + CPT, SIT + CPT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MICT + CPT, HIIT + CPT, SIT + CPT	Behavioral	Single acute intervention, each exercise mode had a washout period of at least 7 days.	Control group sleep disorder group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	Immediately after each intervention and 30 minutes later.
Ankle-brachial index (ABI)	The change of ABI before and after intervention.	Immediately after each intervention and 30 minutes later.

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure	The change of blood pressure before and after intervention.	Immediately after each intervention and 30 minutes later.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Sports Medicine and Rehabilitation, Beijing Sport University		Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D009043	Motor Activity
D012893	Sleep Wake Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D009422	Nervous System Diseases
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000708228	2-cyclohexylidenhydrazo-4-phenyl-thiazole

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided