An Intensive Lifestyle Intervention Program in CKD (Move to Health 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Physical Function Measure
研究概览
简要总结
The primary purpose of the current 6-month study is to determine the effect of an integrated, comprehensive, individualized, intervention program including dietary, exercise, pharmacy, and behavioral counseling on patient performance of the short physical performance battery (SPPB) which gives an indication of an individual's ability to perform activities of daily living dependent upon lower extremity function. Additional objectives include the impact of the intervention on cardiovascular risk factors, and the impact of the intervention on other indices of physical function in stage 3-4 CKD patients. The investigators hypothesize that patients who participate in this integrated, intensive, individualized lifestyle intervention will have higher SPPB scores compared to individuals in the usual care group. The investigators also hypothesize that this approach will lead to higher adherence rates to the lifestyle recommendations and that those who adhere will also show better improvements in the measured variables over time compared to patients who are randomly assigned to the usual care group or who comply poorly with the various study components.
详细描述
The study will be advertised at Renal and Transplant Associates of New England (RTANE) and interested patients will be screened and cleared by nephrologists from RTANE to make sure that they do not have any contraindications to exercise as described by the American College of Sports Medicine. Those patients who are eligible (stage 3-4, eGFRs 15-59 ml/min/1.73m2) to participate, and who want to be involved , will be asked to read and sign a consent form, which had been reviewed and approved by the Institutional Review Board of Springfield College. This signing will take place at RTANE prior to coming to the College.
Individuals will be randomly assigned to either the lifestyle intervention group or the usual care group. During the course of the study, serum potassium levels will be monitored on a monthly basis in all patients. For individuals randomized to the intervention group, if their levels are greater than 5.2 mEq/L, these patients will be prescribed Veltassa according to the recommended dosing scheme. Individuals randomized to the usual care group will be under the care of their physicians and will receive the current standard of care. They will be able to take Veltassa, if prescribed by their physician, but this will not be required by the study protocol. At baseline, and at month 6, when the blood samples are taken for potassium assessment, some of the sample will also be used for the assessment of other biomarkers that will be tracked in this study (e.g., phosphorus, inflammatory markers, etc) After 6 months of participation in the study, individuals will be retested with the same protocols used at baseline.
Pretest instructions: Following the signing of the consent form, patients will be given instructions as to how to complete a 3-day diet log. Patients will be asked to complete the Exercise Benefits/Barriers Scale (EBBS) and they will be expected to send these completed forms to the faculty at Springfield College prior to arriving at the College for their day-long program.
Program Day: Patients will be expected to come to Springfield College on a Saturday and participate in the program from 8:45 am to approximately 4 PM depending upon their group assignment. Upon arrival at the College, participants will be asked to have all the medications and over-the-counter drugs documented by clinical Pharm D researchers. Any participants who had not previously submitted their dietary information prior to coming will be asked to submit their logs at that time and a member of the research team will take their records and analyze them during the time while they are undergoing the other assessments.
Assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be stage 3-4 of CKD (GFR 15-59 ml/min/1.73m2)
- •Must be between the ages of 18-75 years old,
- •Must be capable of complying with and following the study protocol(diet and exercise)
- •Must be capable of independently giving informed consent
排除标准
- •if the patient is currently on Veltassa
- •if in an exercise program,
- •if the patient suffers from severe constipation,
- •if they have bowel obstruction
- •if they have impaction
- •if the patient has post-operative motility disorders (i.e., GI disorders).
研究组 & 干预措施
Lifestyle intervention
Behavioral: The Lifestyle arm is the experimental group that will be exposed to an intensive, individualized approach aimed at assisting these CKD patients to adhere to lifestyle changes that are expected to be beneficial to their health and wellbeing. Patients will receive direction to implement a plant based diet, along with more physical activity in their lives. They will be assisted with the optimal use of their prescribed medications by pharmacy professionals and they will receive behavioral counseling by experts in that area.
干预措施: Lifestyle Intervention (Behavioral)
Usual Care
The Usual Care arm will continue to receive the current standard of care involving all the services provided at a contemporary nephrology practice in Western Massachusetts
结局指标
主要结局
Physical Function Measure
时间窗: 6 month intervention
Short Physical Performance Battery
次要结局
- KDQOL-SF(6 months)
研究者
Samuel A. E. Headley, Ph.D FACSM
Professor of Exercise Science
Springfield College