Ancillary Study of the Lessening Incontinence With Low-impact Activity Study

Study Overview
=================
Brief Summary
-----------------
The parent trial that supports this ancillary research is a randomized controlled trial to evaluate the efficacy of a group-based yoga intervention to decrease the frequency and impact of urinary incontinence in ambulatory middle-aged and older women. Women aged 45 years and older who report daily or more frequent stress-, urgency-, or mixed-type incontinence, are not already engaged in formal yoga or muscle stretching/strengthening programs, are willing to temporarily forgo other clinical treatments for incontinence, are able to walk to and use the bathroom without assistance, and meet other eligibility criteria are being recruited from multiple locations surrounding the San Francisco Bay area. Following a series of telephone- and then clinic-based screening assessments, including a voiding diary to confirm the frequency and clinical type of incontinence, eligible women are randomized in a 1:1 ratio to participate in either a 3-month yoga program (N 120) or a time-equivalent, non-specific muscle stretching and strengthening control program (N 120). During the 3-month intervention period, participants participate in structured intervention programs (either yoga-specific or muscle stretching-strengthening) consisting of twice weekly, 90-minute group classes led by trained instructors). They are also be instructed to practice their assigned intervention for at least an additional hour per week, with the assistance of participant manuals created by the study team and a set of home yoga or stretching/strengthening exercise props. For this ancillary trial research, the investigators are examining ancillary measures of a) physical performance status, b)perceived stress, depression, and anxiety symptoms, and c) sleep quality, duration, and continuity, already incorporated by the principal investigator into the parent trial. The investigators will examine prospective relationships between these ancillary measures and participant-reported urinary incontinence frequency/severity/impact, examine intervention effects on these ancillary outcomes, and assess the extent to which these ancillary outcomes mediate intervention effects on incontinence frequency/severity/impact.

Official Title
-----------------
Ancillary Study of a Randomized Controlled Trial of a Group Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Behavioral: Yoga Practice Program
* Behavioral: Physical Conditioning Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 45 years or older who report urinary incontinence starting at least 3 months prior to screening Self-report an average of at least one incontinence episodes per day voiding diary Self-report urgency-predominant (i.e., at least half of incontinence episodes being urgency-type), stress-predominant (i.e., at least half of episodes being stress-type), or mixed-type (i.e., an equal number of stress- and urgency-type episodes) incontinence on the screening voiding diary Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study intervention period Exclusion Criteria: Current participation in organized yoga classes or workshops, or any prior organized yoga training directed specifically at improving incontinence Current participation in organized physical conditioning classes involving muscle strengthening exercises (e.g., Pilates) Current urinary tract infection or hematuria detected by urinalysis at screening visit (women can re-present after evaluation and treatment through their usual care) Report use of medical devices (i.e. pessary) for incontinence within the past month (participants may stop use of device and re-present for study) Report use of bladder botox, electrostimulation, formal bladder training, or formal pelvic floor exercise training (with certified practitioners) in the past 3 months Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months Unable to walk 2 blocks on level ground without assistance (functional capacity < 4 metabolic equivalents) Unable to get up from a supine to a standing position without assistance (assessed during the screening visit) Report history of interstitial cystitis, bladder or rectal fistula, or congenital defect causing urinary incontinence Report incontinence caused by a major neurologic conditions such as multiple sclerosis, spinal cord injury, or Parkinson's disease Report use of medications with strong effects on urination (anticholinergic bladder medications, beta-3 agonists, tricyclic antidepressants, mirabegron, loop diuretics) within the past month Report starting, stopping, or changing the dose of a medication with the potential to affect anxiety or depression symptoms (i.e., selective serotonin reuptake inhibitors, anxiolytics/sedatives, antipsychotics) within the past 1 month, or plans to start, stop, or change to dose of such a medication during the study period Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study Unable to understand study procedures, complete study interviews, or and provide informed consent in English Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Program<br>The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. | Behavioral: Yoga Practice Program<br>* 3 month group yoga classes<br>|
| Active Comparator: Physical Conditioning Program<br>The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist. | Behavioral: Physical Conditioning Program<br>* 3 month group physical conditioning classes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in One-legged Balance Test (Winsorized) | Assess change in successive semi-tandem, tandem, and one-legged balance stand tests, in which their ability to hold each position for up to 30 seconds. Scoring is based on the number of seconds in which the participant is able to hold the one-legged balance position, ranging from 0 to 30. If a participant cannot make it through the semi-tandem and tandem stands, the one-legged balance will not be attempted. They will receive a score of zero for the one-legged balance. Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points | Repeated change from baseline to 6 and 12 weeks | 
| Change From Baseline in Chair Stands (in 30 Seconds) | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates better quality of life | Repeated change from baseline to 6 and 12 weeks | 
| Change From Baseline in 2-Minute Step Test | Assess change in aerobic endurance. In this test of aerobic endurance for older adults, participants are asked to step in place as many times as possible in a 2 minute period, each time raising the knee to a level midway between the patella and iliac crest. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher scores indicating greater endurance. | Repeated change from baseline to 6 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Perceived Stress Scale (PSS) Score | Assess change in total score on Perceived Stress Scale (PSS), a 10-item measure of thoughts and feelings related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40; higher scores indicated greater perceived stress. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points | Repeated change from baseline to 6 and 12 weeks | 
| Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | Assess change in total score on Center for Epidemiologic Studies Depression (CES-D) scale, a validated 20-item self-administered questionnaire measure that has been widely used in clinical trials, including trials of bladder interventions, and has been shown to be sensitive to change. Total scores range from 0 to 60, with higher scores indicate greater burden of depression symptoms. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points | Repeated change from baseline to 6 and 12 weeks | 
| Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait | Assess change in somatic anxiety. Somatic anxiety (i.e., the affective component of anxiety believed to be related to autonomic physiological arousal response) is measured using the trait component of the Spielberger State Trait Anxiety Inventory (STAI), a 20-item self-administered measure validated in clinical populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points | Repeated change from baseline to 6 and 12 weeks | 
| Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Range 0-21, Higher score indicates lower quality of life | Repeated change from baseline to 6 and 12 weeks | 
| Change From Baseline in Wake After Sleep Onset (Winsorized) | Assess change in sleep disruption. Average time spent awake after initial sleep onset is also assessed using the Pittsburgh Sleep Diary, based on participant recordings of nocturnal awakenings after initially falling asleep. Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates lower quality of life. | Repeated change from baseline to 6 and 12 weeks | 
| Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score | Assess change in global sleep quality. Subjective sleep quality is being assessed using the Pittsburgh Sleep Quality Index (PSQI), an 18-item validated questionnaire originally designed to assess sleep quality, latency, efficiency, and problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points | Repeated change from baseline to 6 and 12 weeks | 
| Change From Baseline in Total Sleep Time | Assess change in average nightly sleep duration. Average total sleep duration is assessed using the Pittsburgh Sleep Diary is a daily self-report measure previously validated against actigraphy data, and used in multiple past studies of older adults. Change from baseline in Total sleep time. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. | Repeated change from baseline to 6 and 12 weeks |