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

Sponsor
Anhui Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05843591
Collaborator
(none)
90
1
4.1
21.7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: aerobic exercise or Tai Chi Chuan interventions

Study Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
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
Actual Study Start Date :
Feb 4, 2022
Actual Primary Completion Date :
Jun 3, 2022
Actual Study Completion Date :
Jun 10, 2022

Arms and Interventions

Arm 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:
  • aerobic exercise
  • Tai Chi Chuan
  • 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:
  • aerobic exercise
  • Tai Chi Chuan
  • 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:
  • aerobic exercise
  • Tai Chi Chuan
  • Outcome Measures

    Primary Outcome Measures

    1. Smartphone Addiction Scale-Short Version (SAS-SV) [2 months]

      Problematic mobile phone use levels

    Secondary Outcome Measures

    1. Zung's Self Rating Depression Scale (SDS) [2 months]

      Depression levels

    2. Zung's Self-Rating Anxiety Scale (SAS) [2 months]

      Anxiety levels

    3. Rosenberg self-esteem scale (RSES) [2 months]

      Self-esteem levels

    4. General Self-Efficacy Scale (GSES) [2 months]

      Self-Efficacy levels

    5. Pittsburgh Sleep Quality Index (PSQI) [2 months]

      Sleep Quality levels

    6. Fatigue Scale-14 [2 months]

      physical and mental fatigue levels

    7. Intestinal flora [2 months]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 22 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Medical University Hefei Anhui China

    Sponsors and Collaborators

    • Anhui Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kexin Zhang, professor, Anhui Medical University
    ClinicalTrials.gov Identifier:
    NCT05843591
    Other Study ID Numbers:
    • KZhang
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kexin Zhang, professor, Anhui Medical University

    Study Results

    No Results Posted as of May 6, 2023