A Walking Intervention to Improve Fatigue and Quality of Life in Lupus: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Fatigue
研究概览
简要总结
Background: Fatigue is a major concern to individuals with lupus, persisting even when disease activity is clinically minimal, and impacting almost all quality of life domains. Studies show cross-sectional correlations between fatigue and physical activity levels in lupus. Some previous physical activity interventions have been tested in lupus and shown modest, although inconsistent, effects on fatigue. However, all of these interventions have been resource-intensive, requiring structured activities or special facilities, increasing barriers to access, dissemination, and widespread implementation.
Focus Area: Improving quality of life for individuals living with lupus, with emphasis on symptom control and challenges that when addressed make day-to-day living with lupus easier and life more fulfilling.
Objective and Hypotheses: The proposed study will test a simple pedometer-based walking intervention, based on an intervention previously implemented in rheumatoid arthritis with successful results in reducing fatigue. The intervention will address weaknesses in previous physical activity interventions in lupus that may have limited their impact.
Hypothesis 1: Individuals in the intervention arm will achieve greater increases in physical activity than individuals in the control group.
Hypothesis 2a: Individuals in the intervention arm will experience greater reductions in fatigue compared to baseline than the control group.
Hypothesis 2b: Individuals in the intervention arm will experience greater improvements in other domains of quality of life (e.g., pain interference, perceived cognitive function, sleep disturbance, depression, anxiety) compared to baseline than the control group Hypothesis 2c: Greater increases in activity will be associated with greater reductions in fatigue and improvements in other domains of quality of life.
Specific Aims Aim 1: Test the impact of a pedometer-based physical activity intervention on activity levels in persons with systemic lupus erythematosus (SLE) using a randomized controlled trial design.
Aim 2: Test the impact of the physical activity intervention on fatigue levels and other domains of quality of life, including physical functioning, pain interference, depressive symptoms, cognitive symptoms, social functioning, and sleep disturbance, in persons with SLE.
Research Strategy: We will test the effect of a walking intervention on increasing physical activity and decreasing fatigue, as well as improving other aspects of quality of life. After objective assessments of physical activity at baseline, participants will be randomized to one of two groups (n = 57 in each group): an intervention group that will receive a pedometer/activity monitor plus individualized step targets or a wait-list control group. The intervention will direct gradual increases in activity; specifically, increases of 10% every two weeks, initially based on the baseline activity assessment. Both groups will be followed over 21 weeks with the same measurements and contacts. Objective measurements of activity will be repeated at weeks 10 and 20. At the end of the 21-week period, the wait-list control group will begin the intervention. The intervention group will have a follow-up 4 months after the end of the intervention to assess maintenance of activity, fatigue, and other quality of life domains. The proposed study will leverage two existing cohort studies and two active lupus clinics for recruitment and an intervention protocol successfully implemented in a study targeting fatigue in rheumatoid arthritis. The study team is uniquely qualified to perform the proposed work, including investigators with expertise in clinical studies of lupus, clinical care of persons with lupus, design and implementation of physical activity interventions, objective measurement of activity, and design and analysis of clinical trial data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatologists' diagnosis of SLE. Diagnoses will be confirmed in medical records before recruiting individuals in clinical settings. Diagnoses for all participants in the existing LOS and CLUES cohorts have already been verified.
- •English or Spanish verbal fluency.
- •Ability to travel to study site for the three in-person visits.
- •Presence of ≥moderate levels of fatigue. The PROMIS Fatigue Short Form 8a will be administered for screening
- •This scale is available in English and Spanish and has a raw score range of 0 -
- •Moderate fatigue will be defined as a raw score ≥
- •In PARAFit, only ~11% of potential participants were screened out because of low levels of fatigue.
排除标准
- •Currently engaging in regular exercise. Current exercise levels will be assessed with the short form of the International Physical Activity Questionnaire (IPAQ), a validated self-report measure of activity 48, during screening. Individuals meeting the IPAQ criterion for high activity will be excluded. For comparison, in one of our previous studies in SLE, fewer than 25% reported high levels of activity according to the IPAQ.
- •Non-ambulatory or presence of a condition or comorbid disease that would limit the ability to engage in walking (e.g., myocardial infarction in past 6 months, stroke, congestive heart failure, severe chronic obstructive pulmonary disease). Individuals who are able to walk with an assistive device such as a cane will be eligible, per medical advice.
- •Planned surgery during the study period. Depending on the procedure and timing, these individuals may be eligible at a later date.
- •Currently pregnant. While pregnancy does not prohibit exercise, it may lead to confounding of fatigue, either during pregnancy or after delivery.
研究组 & 干预措施
Intervention
The intervention group will receive a pedometer and instruction in monitoring their daily step counts using either an online portal (e.g., through REDCap) or a paper diary. We plan to use the Fitbit Inspire®, which is worn on the wrist as the pedometer.
The intervention group will receive step targets for the study period based on their baseline week activity level. Step targets will be calculated to increase participants' average daily step counts by 10% for every 2 weeks of the intervention period.
Participants who were initially randomized to the intervention group will be contacted by phone 4 months after the completion of their study period. The intent of this call is to assess whether they have continued with the activity program and whether they have continued to use the Fitbit in any other way.
干预措施: guided increases in daily walking (Behavioral)
Waitlist control
Controls will be told that they will be eligible to enter the intervention 20 weeks later. The control group will have follow-up contacts at the same times as the intervention group during the waitlist period to account for potential social effects of the intervention protocol. The control group will also be asked to undergo objective activity monitoring at the same time points as the intervention group.
结局指标
主要结局
Fatigue
时间窗: From beginning to end of intervention phase, approximately 20 weeks
Fatigue will be measured with the Patient Reported Outcome Measurement Information System (PROMIS) Fatigue8a at baseline, mid-point, and the final week of monitoring. The scale is reported as T-scores, with mean of 50 and standard deviation of 10. T-scores range from 33.1 to 57.5, with higher scores reflecting greater fatigue. The PROMIS Fatigue scale has been demonstrated to be valid and reliable in both English- and Spanish-speaking SLE patients. This scale is currently being used in our CLUES cohort, as shown in preliminary data. The minimal important change in the PROMIS Fatigue scale has been identified as \~3 points.
Physical activity, measured as average steps/day
时间窗: From beginning to end of the intervention phase, approximately 20 weeks
The Actigraph will provide step and activity data for 7 days at baseline, midpoint, and the final week of monitoring. These data will be aggregated to calculate an average number of steps/day and average daily time in moderate or vigorous activity, which will be used will be used as the primary measures of physical activity. The Actigraph also yields sedentary time, which can be used as a secondary measure of activity
Activity
时间窗: From beginning to end of the intervention phase, approximately 20 weeks
The Actigraph will provide step and activity data for 7 days at baseline, midpoint, and the final week of monitoring. These data will be aggregated to calculate an average number of steps/day and average daily time in moderate or vigorous activity, which will be used will be used as the primary measures of physical activity. The Actigraph also yields sedentary time, which can be used as a secondary measure of activity
次要结局
- quality of life(from beginning to end of intervention period, approximately 20 weeks)