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

April 25, 2023 updated by: Kexin Zhang, Anhui Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Smartphone Addiction Scale-Short Version (SAS-SV)
Time Frame: 2 months
Problematic mobile phone use levels
2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Zung's Self Rating Depression Scale (SDS)
Time Frame: 2 months
Depression levels
2 months
Zung's Self-Rating Anxiety Scale (SAS)
Time Frame: 2 months
Anxiety levels
2 months
Rosenberg self-esteem scale (RSES)
Time Frame: 2 months
Self-esteem levels
2 months
General Self-Efficacy Scale (GSES)
Time Frame: 2 months
Self-Efficacy levels
2 months
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 2 months
Sleep Quality levels
2 months
Fatigue Scale-14
Time Frame: 2 months
physical and mental fatigue levels
2 months
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).
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anhui Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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