Testing of an Innovative Patient-Centered Physical Activity Program for Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 5
- 主要终点
- Change in Physical Activity Levels
研究概览
简要总结
Individuals undergoing HD generally have very low physical activity levels, which consequently contributes to elevated levels of perceptions of fatigue, poor physical function, and a decline in overall quality of life, all of which are linked to progressively greater risk for comorbidities and mortality. The various benefits of physical activity for the general population are well understood, showing a dose-response relationship between physical activity and health. While CKD is not reversible, exercise is often encouraged for its potential to slow disease progression, reduce symptom burden, and improve transplant readiness for HD patients. Over the last two decades, efforts have been made to increase physical activity levels in HD patients, yet the benefits are inconsistent and limited. Many interventions have implemented physical activity programs that include simplistic exercise prescriptions, including intradialytic cycling and/or light resistance exercises. These general, non-personalized exercise programs are associated with poor adherence, high dropout rates, and conflicting effects on physical function or other outcomes related to quality of life. As such, many have discussed the need for individualized exercise prescriptions to overcome the barriers that prevent HD patients from meeting national guidelines for exercise.
In this context, the purpose of this study is to compare the efficacy of a personalized, novel intervention (intervention) compared to a standard of care intervention (comparator), and its effect on perceptions of fatigue, self-reported depression, and physical function. Our primary hypothesis is that the intervention group will elicit greater improvement in physical activity levels than the comparator group. Our secondary hypothesis is that the intervention group will elicit greater improvements in perceptions of fatigue, self-reported depression, and physical function than the comparator group.
详细描述
We have designed a novel physical activity intervention that is designed to overcome many of the barriers to increasing physical activity in this population. The novel physical activity program (intervention group) included 2 phases, a structured phase and a self-directed phase. During the structured phase (weeks 0 through 11), the primary goal was to increase physical activity levels. During the self-directed phase (weeks 13 through 24), the primary goal was to encourage continued physical activity by promoting greater participant autonomy.
The rationale for this approach is that participants are able to choose activities that are important to them, as opposed to prescribed mandated exercises they may not value or benefit from. In brief, it involves working one-on-one with patients to develop an activity prescription that aims to increase the participants' physical activity levels in a sustainable way. Participants had autonomy in selecting their preferred activities, including supervised intradialytic exercises (e.g., cycling or resistance training); at-home exercise (e.g., aerobic, resistance, balance, and flexibility exercises), and lifestyle activities (e.g., gardening, household chores, walking, etc.). This contrasts with what is normally done, which is to assign specific types of exercise that they may not be motivated or willing to do.
If randomized into the control group, this standard of care group aimed to promote engagement in PA during dialysis treatments, similar to the structure of previous studies. Participants in the comparator group were offered a host of supervised intradialytic exercises, including cycling, and 4 resistance exercises: knee flexion, knee extension, calf raises, and seated marching. Participants were met with during each dialysis treatment (approximately 3 times per week, as scheduling allowed) throughout the entire study period t and support progression were encouraged to progress as tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •≥ 18 years old (no upper age limit);
- •Chronic hemodialysis for ≥ 3 months;
- •No planned or expected change in dialysis modality, elective surgery, or relocation during the study period (24 weeks);
- •Able to communicate in English or Spanish and provide written informed consent;
- •Assessed to be safe and able to exercise by the Hemodialysis unit nephrologist
排除标准
- •Physical Activity: patients currently participating in prescribed exercise.
- •Physician Clearance: Patients who do not receive physician clearance to participate in the study will be excluded from the study.
研究组 & 干预措施
Novel Physical Activity Group
The novel PA program included 2 phases, a structured phase and a self-directed phase. During the structured phase, the primary goal was to increase PA levels. Participants had autonomy in selecting their preferred activities, including supervised intradialytic exercises (e.g., cycling or resistance training); at-home exercise (e.g., aerobic, resistance, balance, and flexibility exercises), and lifestyle activities (e.g., gardening, household chores, walking, etc.). Participants were encouraged to progress their PA over time by gradually increasing exercise duration or intensity. During this phase, participants were met with during each dialysis session as scheduling allowed.
During the self-directed phase. the primary goal was to encourage continued PA by promoting greater participant autonomy. Participants determined the frequency of their visits and goal-setting meetings with the research staff, but were met with at least once per week.
干预措施: Novel Physical Activity Program (Behavioral)
Standard of care physical activity group
The standard of care PA program aimed to promote engagement in PA during dialysis treatments, similar to the structure of previous studies14,17,19,20,23. Participants in the comparator group were offered a host of supervised intradialytic exercises, including cycling (Monark information), and 4 resistance exercises: knee flexion, knee extension, calf raises, and seated marching. Participants were met with during each dialysis treatment (approximately 3 times per week, as scheduling allowed) throughout the entire study period to ensure exercises were performed correctly and support progression as appropriate. Participants were encouraged to progress as tolerated. Progression strategies included increasing resistance or exercise duration.
干预措施: Standard of Care Physical Activity Program (Behavioral)
结局指标
主要结局
Change in Physical Activity Levels
时间窗: Week 0, week 11, week 23
MET minutes (physical activity time and intensity) based on the 2011 Compendium of Physical Activities.
次要结局
- Change in Fatigue(Week 0, week 11, week 23)
- Change in Depressive symptoms(Week 0, week 11, week 23)
- Change in Physical function(Week 0, week 11, week 23)
研究者
Kenneth Wilund
Director of the School of Nutritional Science and Wellness
University of Arizona