Effect of Chair Yoga on Elders With Osteoarthritis

Consenting Procedure

An informed consent was obtained from the participants, followed by screening for eligibility. The Project Directors, the PIs, or data collectors discussed the project and obtained the informed consent. At the two study sites, all participants lived independently and were able to sign informed consent. If changes to the study design or program were made, new consents were obtained from all participants after IRB and NCCIH's approval. One copy of the consent was provided to the participant and one copy was kept in a file in the PIs' office in a locked file cabinet. An ID number was assigned to each participant and placed on the second copy of the consent form.

Randomization: Each participant who met the eligibility criteria and who signed informed consent was given an ID number from that list. An overall list of participants with ID numbers were created by the Project Director as participants are enrolled. Participants were enrolled within the 1-week time frame described in the protocol, the outside statistician sent a randomization pattern to the Project Director at each site. The Project Directors matched the randomization pattern with the list of participants to determine to which arm of the study each participant was assigned.

The study statistician, the two Principal Investigators(PIs), and the two Project Directors were responsible for data management. Dr. Newman and the two PIs reviewed all data collection forms on an ongoing basis for data completeness and accuracy, as well as for protocol compliance. They supervised the Project Directors at each site. All the research members including PIs, Project Directors, data collectors, and yoga and HEP instructors completed safety training. All completed forms, including demographic information, were secured in a locked cabinet in primary statistician office at FAU.

The statistician and his research assistant entered data independently (double data entry) using password-protected access to the SPSS data entry system after data collection period (baseline, 4 weeks, 8 weeks, and 1 month and 3 months after intervention). They compared the databases for data entry error and will check the error rate. All data were backed up on FAU secure servers. The primary statistician (Dr. Newman) cleaned the data and randomly selected 10% of all cases in each data entry batch to check for data entry error. An examination of each statistical model was conducted to examine the normality of the residuals and to look for outliers and overly-influential data points. The PIs met with the primary statistician, the Project Directors, and the RAs on a regular basis to discuss progress in data entry, data analysis and interpretations of the results, and other issues related to data management.

SAFETY ASSESSMENTS:

Study progress and safety were reviewed quarterly. The study statistician, PIs, Project Directors, and Data and Safety Monitoring Committee (DSMC) reviewed AE rates. Progress reports, including participant recruitment, adherence and retention/attrition, were provided to the DSMC following each quarterly review. The quarterly report included a list and summary of adverse events (AE), using ID numbers only. The report was sent to the DSMC of independent monitors and forwarded to the IRB and NCCIH. The IRB reviewed progress of the study annually and the PI sent the final/closing report to IRB in November 2016.

An adverse finding from attending the Chair Yoga session could include increased pain, muscle ache/cramping, fatigue, or any combination of these.

A serious adverse event (SAE) is any AE that results in one or more of the following outcomes regardless of relationship to study intervention:

• A life-threatening event
• Inpatient hospitalization or prolongation of existing hospitalization
• A persistent or significant disability/incapacity
• An important medical event, based on appropriate medical judgment

Measurement Tools:

Ten measurement tools will be used to determine the effect of the Sit N Fit Chair Yoga program and the Health Education Program on the study outcome measures. These tools are:

Western Ontario and McMaster Universities Arthritis Index (WOMAC) PROMIS Pain Interference Scale Gait Speed Six-Minute Walk Test (6MWT) Berg Balance Scale PROMIS Physical Function Short Form PROMIS Fatigue Scale Short Form Life Satisfaction Index for Third Age, Short Form (LSITA-SF) PROMIS Ability to Participate in Social Roles and Activities Short Form PROMIS Emotional Distress-Depression Short Form

Data Analyses

Analyses were performed using SPSS software, version 23.0 (IBM) and HLM 7.01 (SSI International). The Missing Value Analysis function in SPSS was employed to ascertain the extent, randomness, and pattern of missing data. Hierarchical linear models (HLM) were used to analyze change over time for each participant. Depending on the nature of the change function, parameter estimates were calculated for intercept, slope and, if necessary, curvature to create the best predictive model fit. Because HLM shows longitudinal changes as a function of time, the time variable was centered at the baseline. The results for the fixed-effects model were used to report the treatment effects for both 8-week ITT assessment and 3-month post-intervention. The random effects model assessed overall changes in all outcomes over the same time periods.