Activation for Self-Care Needs in Older Adults With Chronic Kidney Disease: ACTIVE SENIORS With CKD
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility, as measured by a numerical percentage of all participants who consented out of those eligible
研究概览
简要总结
This is a pilot trial of a 16-week physical activity and power training program among up to 30 Veterans/arm with advanced chronic kidney disease. The trial aims to test whether the program is tolerable to Veterans.
详细描述
This will be a randomized controlled pilot trial of a 16-week physical activity and power training intervention trial among up to 30 pre-frail Veterans with Stage 3B-5 chronic kidney disease. The intervention will contain in-center and at-home components. It will lay the foundation for a large-scale future randomized controlled efficacy trial aimed to reduce frailty risk among Veterans with advanced chronic kidney disease. Up to 30 other Veterans will be part of an attention control.
The outcomes of this pilot trial are feasibility, acceptability, and fidelity. Each of these outcomes will be measured using quantitative surveys and data review as well as qualitative assessments among Veterans at trial close. As this is a pilot feasibility trial, it is intentionally not powered to detect whether the intervention has a significant effect on physical activity frequency, muscle strength, or physical frailty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
All research assistants and biostatistics personnel will be masked to each participant's assignment. Participants and study staff are unaware of group allocation at the time of recruitment and baseline assessments because randomization is performed after participants have completed baseline assessments. However, there is no blinding to group allocation after randomization.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant's nephrologist and/or primary care physician agree that participant may enroll in trial
- •Participants classified as pre-frail per Fried Frailty phenotype due to slowness (time taken to walk 15 feet is greater than 6 seconds) in Aim 1, OR who report 'YES' to any of the following:
- •"For health or physical reasons, do you have difficulty in walking a mile (5-6 blocks)?", OR
- •"If no, have you changed the way you walk half a mile (5-6 blocks) because of underlying health problems?", OR
- •"For health or physical reasons, do you have difficulty in climbing 1 flight of stairs (10 steps)?", OR
- •"If no, have you changed the way you climb 1 flight of stairs (10 steps) because of health problems?"
排除标准
- •Myocardial infarction or unstable angina within the prior six months based on electronic medical record review or self-report
- •Uncontrolled cardiac arrythmia within the prior six months based on electronic medical record review or self-report
- •Systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg on more than one occasion within prior six months based on electronic medical record review or self-report
- •Cerebrovascular event and/or transient ischemic attack within prior six months based on electronic medical record review or self-report
- •Abnormal cardiac stress test within the past year based on electronic medical record review or self-report
- •Hemoglobin of 10 g/dL or less based on electronic medical record review or self-report
- •Class IV heart failure based on electronic medical record review or self-report
- •Dyspnea and/or chest pain at rest
- •Dependence on wheelchair for mobility
- •Permanent residence in nursing home or other long-term care facility
- •Terminal illness or other hospice-qualifying medical condition
- •Planned move away from middle Tennessee within the next year
- •Planned major surgery in the next six months
- •Blindness
- •Concurrent enrollment in physical therapy or structured exercise program
- •Anticipated dialysis or kidney transplant in upcoming three months
- •Non-English speaking
- •Severe cognitive impairment based on electronic medical record review or self-report
研究组 & 干预措施
Power training and monitored physical activity
This is a 16-week power-training and physical activity-focused intervention that contains in-center and at-home components and motivational coaching. Participants will meet 2-3 times per week for the in-center power training. Participants will also be asked to wear accelerometers at home in order for their physical activity frequency to be measured.
干预措施: Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease (Behavioral)
Attention control
This will be the attention control arm that will involve receipt of a physical activity education booklet, use of an accelerometer, and weekly check-in calls. No power training or motivational coaching will be delivered.
干预措施: Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease (Behavioral)
结局指标
主要结局
Feasibility, as measured by a numerical percentage of all participants who consented out of those eligible
时间窗: 4 months
This will be a numeric percentage of participants who consent for the pilot trial out of all eligible participants in Aim 1. This will not be aggregated with any other measure.
Feasibility, as measured by a qualitative description of participants' reasons for declining
时间窗: 4 months
This will be a qualitative description of potential participants' reasons for declining, if applicable. This will not be aggregated with any other measure.
Feasibility, as measured by the questionnaire, the Feasibility of Intervention Measure
时间窗: 4 months
This will be a brief questionnaire known as the Feasibility of Intervention Measure, that asks participants whether the intervention seems doable to them. There are four questions, and participants are asked to rate intervention feasibility from a scale of 1 (Strongly Disagree) to 5 (Strongly Agree). Scores range from 1-5 and are calculated as the mean of all scores. Higher scores indicate greater perceived feasibility. This will not be aggregated with any other measure.
次要结局
未报告次要终点