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NCT Number: NCT05843591

Exercise Interventions on Problematic Mobile Phone Use: 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).

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Key information

Conditions

Exercise Intervention Intestinal Flora Randomized Clinical Trial Tai Chi Chuan

Age range

18 year–22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anhui Medical University

Hefei, Anhui, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

aerobic exercise or Tai Chi Chuan interventions

Behavioral

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

Other names: aerobic exercise, Tai Chi Chuan

Primary outcomes

  1. Smartphone Addiction Scale-Short Version (SAS-SV)

    Time frame: 2 months

    Problematic mobile phone use levels

Secondary outcomes

  1. Zung's Self Rating Depression Scale (SDS)

    Time frame: 2 months

    Depression levels

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

    Time frame: 2 months

    Anxiety levels

  3. Rosenberg self-esteem scale (RSES)

    Time frame: 2 months

    Self-esteem levels

  4. General Self-Efficacy Scale (GSES)

    Time frame: 2 months

    Self-Efficacy levels

  5. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 2 months

    Sleep Quality levels

  6. Fatigue Scale-14

    Time frame: 2 months

    physical and mental fatigue levels

  7. Intestinal flora

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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