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

Exercise Intervention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05843591
• Other study ID #: KZhang
• Status: Completed
• Start date: February 4, 2022
• Est. completion date: June 10, 2022

Study information

• Verified date: April 2023
• Source: Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 10, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 22 Years

Eligibility

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).

Related Conditions & MeSH terms

• Exercise Intervention
• Randomized Clinical Trial

Intervention

Behavioral:
• aerobic exercise or Tai Chi Chuan interventions
8-week aerobic exercise (AE group), 8-week Tai Chi Chuan training (TCC group)

Locations

Country	Name	City	State
China	Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smartphone Addiction Scale-Short Version (SAS-SV)	Problematic mobile phone use levels	2 months
Secondary	Zung's Self Rating Depression Scale (SDS)	Depression levels	2 months
Secondary	Zung's Self-Rating Anxiety Scale (SAS)	Anxiety levels	2 months
Secondary	Rosenberg self-esteem scale (RSES)	Self-esteem levels	2 months
Secondary	General Self-Efficacy Scale (GSES)	Self-Efficacy levels	2 months
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Sleep Quality levels	2 months
Secondary	Fatigue Scale-14	physical and mental fatigue levels	2 months
Secondary	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