NCT05843591

Brief Summary

Problematic mobile phone use (PMPU) has been described as a growing public health issue. This randomized controlled trial aimed to determine if aerobic exercise or Tai Chi Chuan as compared to the wait-list control group decreased PMPU-related symptoms; and to analyze the composition of the intestinal flora in the three study groups to explore the correlation between PMPU scores and flora species. A consecutive sample of 90 college students with PMPU was randomized to the aerobic exercise group (AE group, n = 30), the Tai Chi Chuan group (TCC group, n = 30), or the wait-list control group (WLC group, n = 30). The primary outcome was addiction symptoms, i.e., the PMPU score as assessed by the Smartphone Addiction Scale-Short Version (SAS-SV). Secondary outcomes were the emotion-related symptoms (depression, anxiety, self-esteem and self-efficacy), and physical-related symptoms (sleep quality, physical-fatigue and mental-fatigue). Intervention effects were analyzed via generalized estimated equation analysis (GEE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

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

February 4, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

April 25, 2023

Last Update Submit

April 25, 2023

Conditions

Keywords

Problematic Mobile Phone UseExercise InterventionAerobic ExerciseTai Chi Chuanintestinal flora

Outcome Measures

Primary Outcomes (1)

  • Smartphone Addiction Scale-Short Version (SAS-SV)

    Problematic mobile phone use levels

    2 months

Secondary Outcomes (7)

  • Zung's Self Rating Depression Scale (SDS)

    2 months

  • Zung's Self-Rating Anxiety Scale (SAS)

    2 months

  • Rosenberg self-esteem scale (RSES)

    2 months

  • General Self-Efficacy Scale (GSES)

    2 months

  • Pittsburgh Sleep Quality Index (PSQI)

    2 months

  • +2 more secondary outcomes

Study Arms (3)

Aerobic Exercise group

Participants in the aerobic exercise (AE) group were asked to perform moderate to high intensity regular aerobic exercise. Exercise was required 3 times per week for at least 1 hour each time. At the beginning of the exercise, they were required to sign in at the research personnel, and at the end of the exercise, they were also required to sign out at the research personnel. However, there was no restriction on the type of exercise, which could be running, basketball, badminton, table tennis, tennis, rope skipping, dancing, etc.; there was no restriction on the form of exercise, which could be individual or group exercise; there was no restriction on the period of exercise start, which could be any time of the day to start exercise.

Behavioral: aerobic exercise or Tai Chi Chuan interventions

Tai Chi Chuan group

Participants in the Tai Chi Chuan (TCC) group attended an 8-week Tai Chi training program, which consists of 24-form Tai Chi and Bafa Wubu of Tai Chi. Certified instructors administer and guide Tai Chi Chuan activities. We set up 6 Tai Chi Chuan classes each week, and participants in the Tai Chi Chuan group can participate in any 3 of the 6 classes each week to be considered as completing the task. Each 1-hour training session consists of a brief warm-up stretching session followed by standard Tai Chi routine activities.

Behavioral: aerobic exercise or Tai Chi Chuan interventions

Wait-List Control group

Participants in the wait-list control (WLC) group received no intervention in addition to their usual physical education classes.

Behavioral: aerobic exercise or Tai Chi Chuan interventions

Interventions

8-week aerobic exercise (AE group), 8-week Tai Chi Chuan training (TCC group)

Also known as: aerobic exercise, Tai Chi Chuan
Aerobic Exercise groupTai Chi Chuan groupWait-List Control group

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants were recruited between February 2022 and March 2022. Participants from Anhui Medical University were recruited through promotion in academic departments and student societies as well as advertisements in social media (We-chat and QQ). The coordinator subsequently contacted potential participants via We-chat to provide them with information regarding the study; and determine their interest and eligibility.

You may qualify if:

  • (1) be 18 years or older; (2) college students; (3) fulfill the Smartphone Addiction Scale-Short Version (SAS-SV) criteria for PMPU; (4) have a low level of daily physical activity.

You may not qualify if:

  • (1) regular practice of moderate and higher intensity exercise (Physical activity was measured using the Physical Activity Rating Scale-3 (PARS-3), which is a 3-item self-reported scale comprising intensity, duration and frequency \[14\]. Exercise was considered to be of more than moderate intensity when the PARS-3 scores was \>42); (2) any major disease (cardiovascular disease, respiratory illness, and musculoskeletal disorder) that can affect them to participate in exercise training; (3) any gastrointestinal diseases and other diseases affecting intestinal bacteria; and (4) any severe mental illness (e.g., depression, anxiety, bipolar disorder, obsessive-compulsive disorder, eating disorder, and post-traumatic stress disorder).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Hefei, Anhui, China

Location

Related Publications (1)

  • Zhang K, Guo H, Zhang X, Yang H, Yuan G, Zhu Z, Lu X, Zhang J, Du J, Shi H, Jin G, Ren J, Hao J, Sun Y, Su P, Zhang Z. Effects of aerobic exercise or Tai Chi Chuan interventions on problematic mobile phone use and the potential role of intestinal flora: A multi-arm randomized controlled trial. J Psychiatr Res. 2024 Feb;170:394-407. doi: 10.1016/j.jpsychires.2024.01.012. Epub 2024 Jan 8.

MeSH Terms

Interventions

ExerciseTai Ji

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

February 4, 2022

Primary Completion

June 3, 2022

Study Completion

June 10, 2022

Last Updated

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations