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Clinical Trials/NCT06445413
NCT06445413
Recruiting
Not Applicable

Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery: A Feasibility and Acceptability Study

Hartford Hospital1 site in 1 country24 target enrollmentJanuary 22, 2024
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Hartford Hospital
Enrollment
24
Locations
1
Primary Endpoint
Video view duration
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to evaluate the feasibility and acceptability of a 10-wk hybrid Tai Chi (TC) program with in-person classes and online TC videos among 24 physically inactive adults who are seeking metabolic and bariatric surgery (MBS) in a single-arm trial.

The aims are:

Aim 1: Feasibility: To evaluate whether TC is feasible, defined as a mean attendance rate of ≥70% in-person TC classes attended.

Aim 2: Acceptability: To evaluate whether TC is acceptable, defined as a mean rating of ≥4 across 4 acceptability questionnaire items measured on a 5-point Likert scale (e.g., rate "Tai Chi practice is appealing to me" on a scale from 1 [completely disagree] to 5 [completely agree]).

Participants will complete four individual in-person visits where they will complete study assessments and ten weekly group in-person Tai Chi classes where they will practice Tai Chi with up to 5 other study participants. Additionally, they will be asked to practice Tai Chi at home with the aid of instructional online videos and log their practice.

Registry
clinicaltrials.gov
Start Date
January 22, 2024
End Date
June 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Seeking to undergo MBS at HHC.
  • Be able to give valid informed consent in English. Attending the live, in-person, group TC classes each week is the main component of the intervention. During the classes, the TC instructor will be giving instructions and communicating with the participants in English. It is not practical to having an interpreter during the live classes. Therefore, participation is limited to those who are English speakers.
  • Be 18-70 years of age.
  • Have BMI≥35 kg/m2
  • Absence of cognitive impairment since participants will need to learn and memorize the TC forms. Must score ≥24 Mini-Mental State Examination.
  • Be physically inactive defined as performing \<150 min/wk of moderate to vigorous intensity PA based on self-report.
  • Be able to ambulate independently without use of an assistive device.
  • Be able to complete questionnaires and view TC instructional videos via REDCap.
  • Be able to commute to one of the HH Medical and Surgical Weight Loss Center clinics to participate in testing sessions and in-person TC classes.

Exclusion Criteria

  • Having severe psychological or physical conditions that may impair their ability to adhere to the study protocol such as uncontrolled mental health issues, and severe arthritis.
  • Pregnant women.

Outcomes

Primary Outcomes

Video view duration

Time Frame: Measured once weekly (up to 10 weeks)

Number of minutes the weekly Tai Chi video was played

Home practice frequency

Time Frame: Measured once weekly (up to 10 weeks)

Number of times participant practices Tai Chi at home

Home practice duration

Time Frame: Measured once weekly (up to 10 weeks)

Number of minutes spent practicing Tai Chi at home

Attendance

Time Frame: Attendance will be taken at each class (up to 10 weeks)

Percentage of Tai Chi classes attended over 10 week program

Video view frequency

Time Frame: Measured once weekly for up to 10 weeks

Number of times the weekly Tai Chi video is viewed

Acceptability of Tai Chi

Time Frame: Measured once at the end of Tai Chi class or when participant drops out

This is a validated tool to assess the acceptability of interventions with four 5-point Likert scale questions that will be rated from completely disagree to completely agree. Acceptability is defined as a mean rating of ≥4 across 4 acceptability questionnaire items measured on a 5-point Likert scale (e.g., rate "Tai Chi practice is appealing to me" on a scale from 1 \[completely disagree\] to 5 \[completely agree\]).

Study Sites (1)

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