NCT06483633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 23, 2024

Last Update Submit

July 1, 2024

Conditions

Keywords

exercisesleep disorderscold pressor testvascular function

Outcome Measures

Primary Outcomes (3)

  • 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 (1)

  • Blood pressure

    Immediately after each intervention and 30 minutes later.

Study Arms (2)

sleep disorder group

EXPERIMENTAL
Behavioral: MICT + CPT, HIIT + CPT, SIT + CPT

Control group

EXPERIMENTAL
Behavioral: MICT + CPT, HIIT + CPT, SIT + CPT

Interventions

Single acute intervention, each exercise mode had a washout period of at least 7 days.

Control groupsleep disorder group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sports Medicine and Rehabilitation, Beijing Sport University

Beijing, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersMotor ActivitySleep Wake Disorders

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2024

First Posted

July 3, 2024

Study Start

August 1, 2022

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations