NCT06182150

Brief Summary

The goal of this clinical trial is to learn about moderate-intensity indoor cycling interventions in women's sport student-athletes transitioning into college and collegiate sport. The main question\[s\] it aims to answer are: Aim 1: Establish preliminary feasibility for the intervention based on recruitment and retention rates. Aim 2: Assess efficacy through comparison of pre- and post-intervention mental health outcomes scores between experimental and control groups. Exploratory Aim 3: Explore associations between exercise, athletic, and academic identities and mental health issues post-intervention. Participants will complete an online questionnaire. This online questionnaire will be given before the program begins and after the 4 weeks. The questionnaire will ask about the participants' basic information, the participants' experience with exercise, and the participants' transition experience including mental, physical, and social factors. Participants will be asked to attend an in-person 45-minute exercise class once a week at the University of North Carolina at Chapel Hill (UNC) Student Recreation Center. Participants enrolled in the program will be asked to complete a self-report form during each weekly practice including heart rate (before and after practice) and ratings of perceived exertion. Heart rate will be measured during practice, smart devices (i.e., Apple Watch, FitBit) are not required.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable depression

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

First Submitted

Initial submission to the registry

December 11, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 29, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

27 days

First QC Date

December 11, 2023

Last Update Submit

February 26, 2024

Conditions

Keywords

Exercise Intervention

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in combined depression, stress, and anxiety symptomatology scores

    The Depression, Anxiety, and Stress Scale (DASS) utilizing 42 items on a 4-point Likert scale ranging from 0 to 3 (0=did not apply to me at all and 3=applied to me very much, or most of the time). Higher scores correlate with greater symptoms of depression, stress, and anxiety.

    Baseline, Week 4

Secondary Outcomes (3)

  • Change from baseline in academic identity scores

    Baseline, Week 4

  • Change from baseline in athlete identity scores

    Baseline, Week 4

  • Change from baseline in exercise identity scores

    Baseline, Week 4

Study Arms (1)

PAUSE-Cardio Moderate-Intensity Exercise Arm

EXPERIMENTAL

Arm receiving moderate-intensity indoor cycling exercise once weekly for 4 weeks.

Behavioral: Moderate-Intensity Indoor Cycling Exercise

Interventions

The 45-minute indoor cycling moderate-intensity cardiovascular exercise will take place once a week over four weeks. The group fitness-based class consists a 5-minute warm-up, a 35-minute conditioning segment, and a 5-minute cooldown.

PAUSE-Cardio Moderate-Intensity Exercise Arm

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsInclusion criteria include participants that self-identify as a women's sport student-athlete.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first- or second-year undergraduate student
  • current participation in women's intramural sport, club sport, varsity collegiate sport, or recreational sport

You may not qualify if:

  • those incapable of providing informed consent
  • did not complete surveys at T1 and T2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Student Recreation Center

Chapel Hill, North Carolina, 27516, United States

Location

Related Publications (5)

  • Anderson DF, Cychosz CM. Development of an exercise identity scale. Percept Mot Skills. 1994 Jun;78(3 Pt 1):747-51. doi: 10.1177/003151259407800313.

    PMID: 8084685BACKGROUND
  • Lochbaum M, Cooper S, Limp S. The Athletic Identity Measurement Scale: A Systematic Review with Meta-Analysis from 1993 to 2021. Eur J Investig Health Psychol Educ. 2022 Sep 14;12(9):1391-1414. doi: 10.3390/ejihpe12090097.

    PMID: 36135235BACKGROUND
  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

    PMID: 7726811BACKGROUND
  • Osborne, J. W. (1997). Identification with Academics and Academic Success among Community College Students. Community College Review, 25(1), 59-67.

    BACKGROUND
  • Qualtrics. (2013). Qualtrics (Version 37,892) [Computer software]. Provo, UT, USA

    BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety DisordersStress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Emily G Thomas

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 26, 2023

Study Start

January 29, 2024

Primary Completion

February 25, 2024

Study Completion

February 25, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations