Exercise InterventionNCT05843591
Exercise Interventions on Problematic Mobile Phone Use: a Multi-arm Randomized Controlled Trial
An observational study of Exercise Intervention and Tai Chi Chuan, run by Anhui Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 22 years
- Conditions the study is for
- Exercise Intervention, Tai Chi Chuan, Intestinal Flora
- What is being tested?
- aerobic exercise or Tai Chi Chuan interventions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2022to 10 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- (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.
Who cannot join
- (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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Being tested
- aerobic exercise or Tai Chi Chuan interventions
- Keywords
- Problematic Mobile Phone Use, Exercise Intervention, Aerobic Exercise, Tai Chi Chuan, intestinal flora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise or Tai Chi Chuan interventionsBehavioural
Also called aerobic exercise, Tai Chi Chuan
8-week aerobic exercise (AE group), 8-week Tai Chi Chuan training (TCC group)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: aerobic exercise or Tai Chi Chuan interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smartphone Addiction Scale-Short Version (SAS-SV)
Problematic mobile phone use levels
Measured: 2 months
Secondary outcomes (7)
Zung's Self Rating Depression Scale (SDS)
Depression levels
Measured: 2 months
Zung's Self-Rating Anxiety Scale (SAS)
Anxiety levels
Measured: 2 months
Rosenberg self-esteem scale (RSES)
Self-esteem levels
Measured: 2 months
General Self-Efficacy Scale (GSES)
Self-Efficacy levels
Measured: 2 months
Pittsburgh Sleep Quality Index (PSQI)
Sleep Quality levels
Measured: 2 months
Fatigue Scale-14
physical and mental fatigue levels
Measured: 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).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start4 Feb 2022
- Primary completion3 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kexin Zhang, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843591
- Sponsor's protocol ID
- KZhang
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38218013
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05843591
- Acronym / sponsor ID
- KZhang
- Keywords
- Problematic Mobile Phone Use, Exercise Intervention, Aerobic Exercise, Tai Chi Chuan, intestinal flora
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise group | – | Behavioral: aerobic exercise or Tai Chi Chuan interventionsParticipants 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. |
| Tai Chi Chuan group | – | Behavioral: aerobic exercise or Tai Chi Chuan interventionsParticipants 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. |
| Wait-List Control group | – | Behavioral: aerobic exercise or Tai Chi Chuan interventionsParticipants in the wait-list control (WLC) group received no intervention in addition to their usual physical education classes. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise or Tai Chi Chuan interventionsAlso: aerobic exercise, Tai Chi Chuan8-week aerobic exercise (AE group), 8-week Tai Chi Chuan training (TCC group) | Behavioural | Aerobic Exercise group, Tai Chi Chuan group, Wait-List Control group |
Primary outcome
Smartphone Addiction Scale-Short Version (SAS-SV)
Time frame: 2 months
Problematic mobile phone use levels
7 secondary outcomes
Zung's Self Rating Depression Scale (SDS)
Time frame: 2 months
Zung's Self-Rating Anxiety Scale (SAS)
Time frame: 2 months
Rosenberg self-esteem scale (RSES)
Time frame: 2 months
General Self-Efficacy Scale (GSES)
Time frame: 2 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2 months
Fatigue Scale-14
Time frame: 2 months
Intestinal flora
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 38218013Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Intervention and Tai Chi Chuan, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smartphone Addiction Scale-Short Version (SAS-SV) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05843591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.