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

NCT06445413 | Recruiting DMC

• 1 other identifier: R-HHC-2023-0177
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Attendance

  Percentage of Tai Chi classes attended over 10 week program

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

• Video view frequency

  Number of times the weekly Tai Chi video is viewed

  Measured once weekly for up to 10 weeks

• Video view duration

  Number of minutes the weekly Tai Chi video was played

  Measured once weekly (up to 10 weeks)

• Home practice frequency

  Number of times participant practices Tai Chi at home

  Measured once weekly (up to 10 weeks)

• Home practice duration

  Number of minutes spent practicing Tai Chi at home

  Measured once weekly (up to 10 weeks)

• Acceptability of Tai Chi

  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 \[completely agree\]).

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

Study Arms (1)

Tai Chi class

EXPERIMENTAL

Participation in ten weekly group in-person Tai Chi classes

Other: Tai Chi

Interventions

Tai Chi OTHER

Ten weekly 60-minute Tai Chi classes

Tai Chi class

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Yin Wu, PhD

CONTACT

860-972-5750; yin.wu@hhchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: June 6, 2024
• Study Start: January 22, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

US (1)