Overview

This trial is active, not recruiting.

Condition osteoarthritis (oa)
Treatments sit 'n' fit chair yoga (snfcy), health education program (hep)
Sponsor Florida Atlantic University
Collaborator National Center for Complementary and Integrative Health (NCCIH)
Start date March 2014
End date June 2015
Trial size 120 participants
Trial identifier NCT02113410, 1R15AT007352-01A1, 420926

Summary

The current study is a randomized controlled clinical trial to test the feasibility of recruiting, randomizing, and having older adults with osteoarthritis (OA) adhere to and safely complete the Sit 'N' Fit Chair Yoga program and the HEP program (primary objective). Secondary objectives of the study are to determine the effect of the Sit 'N' Fit Chair Yoga Program to reduce levels of pain; improve physical function, psychosocial function, and life satisfaction in adults over 65 years of age who are unable to participate in standing exercise. Participants at two sites will be randomly assigned to either the intervention group (Sit 'N' Fit Chair Yoga) or attention control group (Health Education Program). Data collectors will be blinded to group assignments. Data will be collected prior to the intervention (baseline), after 4 weeks, and after 8 weeks. Follow-up data will be collected after 1 month and after 3 months after completion of the intervention to measure the extent to which effects of the intervention continue. Evaluations will include physical measures and self-report measures.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Willing and eligible subjects randomized to Sit 'N' Fit Chair Yoga will attend twice-weekly 45-minute yoga sessions for 8 weeks, for a total of 16 sessions.
sit 'n' fit chair yoga (snfcy)
Experimental: Sit 'N' Fit Chair Yoga - a twice-weekly, 8-week yoga program of 45-minute sessions. Active Comparator: Health Education Program (HEP), a twice-weekly, 8-week program of 45-minute sessions
(Active Comparator)
Willing and eligible subjects randomized to the Health Education Program (HEP) will attend twice-weekly 45-minute health education sessions for 8 weeks, for a total of 16 sessions.
health education program (hep)
Willing and eligible subjects randomized to the Health Education Program (HEP) will attend twice-weekly 45-minute health education sessions for 8 weeks, for a total of 16 sessions.

Primary Outcomes

Measure
Number of participants who attend at least 12 out of the 16 intervention meetings (Sit 'N' Fit Chair Yoga or HEP).
time frame: Data will be collected at baseline, during the fourth and eighth week of the intervention and one month and three months after the intervention has ended

Secondary Outcomes

Measure
Change from baseline to endpoint in reported levels of pain, physical function, and emotional health as assessed by 9 measurement tools.
time frame: Data will be collected at baseline, at the fourth and eighth week of the intervention and at one month and three months after the intervention has ended

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: 1. age 65 years or older 2. living independently in the community and noninstitutionalized at the time of the study 3. self-reported joint pain verified by Dr. McCaffrey and a Project Director (nurse practitioner) to be caused by OA and present in one or more lower extremity joints (hip, knee, foot, or ankle) 4. ability to ambulate independently with or without assistive devices 5. chronic pain at least 15 days of the month for 3 months or longer at a level of at least 4 (moderate pain) on a 0-10 pain bothersomeness scale (0 = no pain to 10 = excruciating pain) 6. self-reported inability to participate in regular yoga or standing exercise due to physical disability, fatigue, fear of falling, or balance problems 7. not currently participating in yoga or any other exercise program 8. ability to understand English or Spanish 9. ability to come to designated site at the scheduled times 10. willingness to be audiotaped during the intervention sessions Exclusion Criteria: 1. Knee surgery (or knee-arthroscopy) or hip(s) within 12 weeks prior to enrollment, causing pain or functional problems 2. Systemic or intra-articular corticosteroid use within 60 days of the screening visit 3. Serious comorbidity that makes it impossible to participate in the yoga intervention (e.g., heart failure-New York Heart Association (NYHA IV) 4. Require assistance by another person (e.g., holding the arm or walking behind) in order to ambulate 30 feet 5. Participation in yoga or exercise program currently or in the previous 3 months, or planning to participate in yoga or other exercise program during the chair yoga intervention (including 3-month follow-up) 6. Intra-articular steroid injections within 4 weeks of screening 7. Inability to understand or speak English or Spanish 8. Inability to correctly answer questions, complete the demographic data form, and continue with yoga practice for 1 month post intervention. This will be measured by asking participants the following questions (Table 1 from the Alzheimer's Association's "questions to determine early cognitive impairment) (http://www.alz.org/alzheimers_disease_10_signs_of_alzheimers.asp) as accessed August 27, 2013, as approved by our geriatric content expert, Dr. Joseph Ouslander). Those who answer three or more of these questions incorrectly will be excluded from the study. 1. What is today's date? 2. What day of the week is today? 3. On what street do you live? 4. In what town do you live? 5. In what state is your town? 6. Who is the President? 7. What season of the year is this? 8. What month are we in now? 9. How did you get here today? Screening Evaluation All participants must have OA. As diagnostic criteria for OA, the participant must exhibit at least three of the following upon history or physical examination to be considered to have a diagnosis of OA and thus to be eligible to participate in the study: - Pain in the affected joint - Morning stiffness that is relieved as the day progresses - Crepitus on active motion - Bony tenderness - Bony enlargement - Decreased range of motion of joint - Joint instability upon standing or bending - Increased pain and fatigue with walking or standing - The participant must ambulate at least 30 feet without assistance from another person (may use cane, walker, or wheelchair). Those who require personal assistance to ambu-late 30 feet (such as needing to hold an arm or to have someone walk behind for safety) will be excluded because they would not be able to complete the 6-Minute Walk or Gait Speed Test. We will not provide assistive devices nor train project staff on the safe use of such devices. During the screening of potential participants each person will be asked whether he or she is able to participate in standing exercise programs or regular yoga programs. The following questions will be asked and people will be eligible if they identify any two of the following: Please check any of the following that you feel unable to do because of balance, pain, fear of falling, fatigue or strength - Standing for 30-45 minutes - Bending over toward your toes - Bending side to side - Squatting - Standing on one foot - Standing, holding your arms outstretched above your head - Twisting your body side to side

Additional Information

Official title Effect of Sit 'N' Fit Chair Yoga on Community-Dwelling Elders With Osteoarthritis
Principal investigator Juyoung Park, Ph. D
Description Consenting Procedure Informed consent will be obtained from the participants, followed by screening for eligibility. Only one consent procedure will be completed, describing both the screening and study procedures. The Project Directors, the PIs, or data collectors will discuss the project and obtain the informed consent. At the two study sites, all participants live independently and are able to sign informed consent. If changes to the study design or program are made, new consents will be obtained from all participants after IRB and National Center for Complementary and Integrative Health (NCCIH) approval. One copy of the consent will be provided to the participant and one copy will be kept in a file in the PIs' office in a locked file cabinet. An ID number will be assigned to each participant and placed on the second copy of the consent form. Randomization: Each participant who meets the eligibility criteria and who signs informed consent will be given an ID number from that list. An overall list of participants with ID numbers will be created by the Project Director as participants are enrolled. Participants have been enrolled, the outside statistician will send the variable permuted block randomization pattern to the Project Director. The Project Director will match the randomization pattern with the list of participants to determine to which arm of the study each participant is assigned. The study statistician, the two PIs, and the two Project Directors will be responsible for data management. Dr. Newman and the two PIs will review all data collection forms on an ongoing basis for data completeness and accuracy, as well as for protocol compliance. They will supervise the Project Directors at each site. All the research members including PIs, Project Directors, data collectors, and yoga and HEP instructors will complete safety training. All completed forms, including demographic information, will be secured in a locked cabinet in primary statistician office at FAU. The statistician and his research assistant will enter 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 will compare the databases for data entry error and will check the error rate. All data will be backed up on FAU secure servers. The primary statistician will clean the data, randomly selecting 10% of all cases in each data entry batch to check for data entry error. An examination of each statistical model will be conducted to examine the normality of the residuals and to look for outliers and overly-influential data points. Non-normal residuals will require modification of the data analysis techniques to allow non-normal distributions to be used. Outliers and influential data points will be examined to determine whether they reflect errors in data entry. Errors will be corrected or designated as missing if not correctable. Outliers and influential data points that are not errors will be noted and discussed in the results. The PIs will meet with the primary statistician, the Project Directors, and the RAs on a regular basis to discuss progress in data entry and other issues related to data management. SAFETY ASSESSMENTS Study progress and safety will be reviewed quarterly. The study statistician, PIs, Project Directors, and Data and Safety Monitoring Committee (DSMC) will review AE rates. Progress reports, including participant recruitment, adherence and retention/attrition, will be provided to the DSMC following each quarterly review. The quarterly report will include a list and summary of adverse events (AE), using ID numbers only. The report will be sent to the DSMC of independent monitors and forwarded to the IRB and NCCIH. The IRB will review progress of the study annually. The PIs will send copies of signed recommendations and comments from the DSMC to the NCCIH Program Officer after each quarterly review. 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 All written reports will be in the format required by the FAU IRB and participants, and whether changes to the informed consent are necessary. SAEs that are unanticipated, serious, and possibly related to the study intervention will cause a discontinuation of the intervention for the participant until the PIs or the two Project Directors (one at each site) receives a note from the participant's physician allowing the participant to re-enter the intervention. Anticipated or unrelated SAEs will be handled in a less urgent manner but will be reported to the DSMC, IRB, and NCCIH in accordance with their requirements. In the annual AE summary, the DSMC will confirm that they have reviewed all SAE reports. Sample Size and Randomization: The purpose of this feasibility study is to compare the effect of the intervention on a sample of the studied population in preparation for a larger clinical trial and future research. Determining effect size of this intervention will enable an accurate calculation of sample size in future research studies. Although this is not a dosage study, it may be possible, depending on adherence, to explore the effect of attendance on outcomes, which could be useful in future research. Based on similar studies of exercise interventions on community-dwelling older adults, it is estimated that a sample size of 100 would be acceptable to address the primary objective and establish an accurate effect size for the Sit 'N' Fit Yoga intervention. In order to oversample by 10% to allow for participant dropout, 120 participants will be recruited: 60 participants (30 HEP and 30 Yoga) at each of two sites. Assignment will create three groups of 10 participants for yoga and three groups of 10 participants for HEP at each site. 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 The primary feasibility outcomes will be assessed using means, frequencies, and percentages, as well as contingency tables, to investigate potential retention and adherence differences across or between groups. The exploratory analysis of the secondary objectives will be conducted in two main stages: (a) preliminary analysis, including descriptive statistics, management of missing data, and testing covariates; and (b) hypothesis testing. The preliminary analyses will use descriptive statistics to investigate the normality of the data. Correlations and multiple linear regression (MLR) will be used to investigate the simple and multiple relationships between groups on levels of physical functioning and psychosocial well-being and on assumptions of homogeneity of variance and independence of error that are required for more sophisticated analytical techniques. Both outliers and multicollinearity will be investigated using Cooks Distance, Variable Inflation Factor (VIF), and Tolerance. Full and restricted regression models will be used as appropriate. Missing Data: With all research studies there is the potential of missing data, especially when data are collected across multiple time points. This study will use the Missing Value Analysis (MVA) function in SPSS to ascertain the extent, randomness and pattern of missing data. This program allows one to investigate the mechanisms of the missing data by assign 1 or 0 to a vector R for each variable that tests whether the data are missing completely at random (MCAR), missing at random (MRM), or missing not at random (MNAR). This analysis will use Maximum Likelihood Estimated and the EM algorithm to test the relationship between missing values across variables. Patterns of missing data will be displayed in tables and figures to facilitate the description of the patterns. Based on the patterns and reasons for the missing values, data will be imputed using multiple imputation, which is widely accepted as superior to single or simple imputation, usually with empirical Bayesian method or stochastic regression imputation. The approach adds a randomly sampled residual term from the normal (or other) distribution to each of the imputed values. By default, that procedure adds a bit of random error to each substitution. After imputation, the data will be analyzed with the completers only and with the imputed data for the ITT. Next, a comparison between the regression slopes of the complete and imputed data will be conducted to determine any differences. These differences will be described and primary analysis with the ITT group will use the imputed data.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Florida Atlantic University.