Exercise Interventions on Problematic Mobile Phone Use: a Multi-arm Randomized Controlled Trial

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

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).

Study Overview

• Status: Completed
• Conditions: Randomized Clinical Trial; Intestinal Flora; Exercise Intervention; Tai Chi Chuan
• Intervention / Treatment: Behavioral: aerobic exercise or Tai Chi Chuan interventions

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• (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.

Exclusion Criteria:

• (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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 8-week aerobic exercise (AE group), 8-week Tai Chi Chuan training (TCC group); Other Names: Tai Chi Chuan; aerobic exercise
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; 8-week aerobic exercise (AE group), 8-week Tai Chi Chuan training (TCC group); Other Names: Tai Chi Chuan; aerobic exercise
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; 8-week aerobic exercise (AE group), 8-week Tai Chi Chuan training (TCC group); Other Names: Tai Chi Chuan; aerobic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smartphone Addiction Scale-Short Version (SAS-SV)	Problematic mobile phone use levels	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zung's Self Rating Depression Scale (SDS)	Depression levels	2 months
Zung's Self-Rating Anxiety Scale (SAS)	Anxiety levels	2 months
Rosenberg self-esteem scale (RSES)	Self-esteem levels	2 months
General Self-Efficacy Scale (GSES)	Self-Efficacy levels	2 months
Pittsburgh Sleep Quality Index (PSQI)	Sleep Quality levels	2 months
Fatigue Scale-14	physical and mental fatigue levels	2 months
Intestinal flora	Fecal microbial DNA was extracted using the QIAamp Fast DNA Stool Mini kit (Qiagen, Hilden, Germany) according to the manufacturer's instructions. All procedures of DNA extraction were performed in a class II biosafety cabinet. Universal primers (341F and 805R) linked with indices and sequencing adaptors were used to amplify the V3-V4 regions of the 16S rRNA gene. The amplification products were detected by agarose gel electrophoresis, and the amplification products were purified by nucleic acid purification beads to obtain the original library of the sample. The library quality was assessed on the Agilent Bioanalyzer 2100 system. The 16S rRNA gene amplification products sequencing was performed with the 2 × 250 bp paired-end method using the Illumina MiSeq Benchtop Sequencer [48] at the Genesky Biotechnologies Inc. (Shanghai, China).	2 months

Collaborators and Investigators

• Sponsor: Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2022
• Primary Completion (Actual): June 3, 2022
• Study Completion (Actual): June 10, 2022

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Aerobic Exercise; Exercise Intervention; Tai Chi Chuan; intestinal flora; Problematic Mobile Phone Use
• Other Study ID Numbers: KZhang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No