Recruiting

Tai Chi

Sponsor:

Hartford Hospital

Code:

NCT06445413

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Tai Chi

Study Details

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.

Conditions

Obesity

Study ID

NCT06445413

Start date

Jan 22, 2024

Status verified date

Jun, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Seeking to undergo MBS at HHC.
2. 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.
3. Be 18-70 years of age.
4. Have BMI≥35 kg/m2
5. Absence of cognitive impairment since participants will need to learn and memorize the TC forms. Must score ≥24 Mini-Mental State Examination.
6. Be physically inactive defined as performing <150 min/wk of moderate to vigorous intensity PA based on self-report.
7. Be able to ambulate independently without use of an assistive device.
8. Be able to complete questionnaires and view TC instructional videos via REDCap.
9. 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:

1. 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.
2. Pregnant women.

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Tai Chi class

Participation in ten weekly group in-person Tai Chi classes

Interventions

Tai Chi

Ten weekly 60-minute Tai Chi classes

Primary outcome measure

  • Attendance [ Time Frame: Attendance will be taken at each class (up to 10 weeks) ]
  • Video view frequency [ Time Frame: Measured once weekly for up to 10 weeks ]
  • Video view duration [ Time Frame: Measured once weekly (up to 10 weeks) ]
  • Home practice frequency [ Time Frame: Measured once weekly (up to 10 weeks) ]
  • Home practice duration [ Time Frame: Measured once weekly (up to 10 weeks) ]
  • Acceptability of Tai Chi [ Time Frame: Measured once at the end of Tai Chi class or when participant drops out ]

Central Contacts and Locations

Central contacts

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

More Information

Sponsor

Hartford Hospital

Last update posted

Jun 6, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2024-06-06.