Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery

NCT ID: NCT06445413

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-22
• Study Completion Date: 2025-06-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Tai Chi class

Participation in ten weekly group in-person Tai Chi classes

Group Type: EXPERIMENTAL

Tai Chi

Intervention Type: OTHER

Ten weekly 60-minute Tai Chi classes

Interventions

Tai Chi

Ten weekly 60-minute Tai Chi classes

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hartford Hospital

Hartford, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yin Wu, PhD

Role: CONTACT

yin.wu@hhchealth.org

860-972-5750

Facility Contacts

Dale Bond, PhD

Role: primary

dale.bond@hhchealth.org

860-972-4318

Other Identifiers

R-HHC-2023-0177

Identifier Type: -

Identifier Source: org_study_id