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| Name | Class |
|---|---|
| The John A. Hartford Foundation | OTHER |
| Association of Subspecialty Professors | OTHER |
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The physical function of older candidates for renal transplantation and their ability to sustain physical activity programs are currently unknown. The primary goal of this study is to determine the feasibility of a physical activity intervention in older dialysis-dependent patients, assessing its effect on maintaining transplant candidacy and outcome after transplantation. Clinical practice guidelines do not set an absolute age limit for evaluating potential renal transplant candidates. While cardiovascular risk assessment and malignancy screening are emphasized in the older age group, physical performance and the risk for disability are often overlooked. Although healthy older patients experience increased life expectancy after renal transplantation versus remaining on dialysis, outcomes such as the capacity to live independently and function well have not been studied. Given the poorer baseline health status in aging end-stage renal disease patients, rapid changes in health on dialysis, and the national organ shortage, it is increasingly important to identify factors that predict better outcomes and devise strategies that will maximize the benefit of transplantation in older individuals.
The investigators hypothesize that muscle is the principal organ system underlying impaired physical function among older transplant candidates, and that decreased muscle mass and physical functioning lead to poorer outcomes in older renal transplant candidates. The investigators propose that a simple bedside performance measurement of lower extremity functional limitations, the Short Physical Performance Battery, will be a strong predictor of outcomes in this patient cohort. The investigators also propose that outcomes can be improved with exercise training, potentially leading to longer durations of active transplant candidacy and greater independence after successful transplantation. The Specific Aims of this research are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | No physical activity intervention will be prescribed for the Usual Care Arm. | |
| Physical Activity | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity | Other | The intervention is an individualized, structured, moderate intensity home-based physical activity program. During the first 12 weeks the program will focus on lower extremity strengthening, and thereafter incorporate cardiovascular activity. The target duration of activity is 150 minutes per week, i.e., 20-30 min on most days of the week. However, the program is adjusted based on each participant's progression, initial level of physical fitness and will be modified in response to illness, injury, or physical symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| The Short Physical Performance Battery SPPB) score, a brief and simple bedside performance-based instrument. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality-of-life scores | One year | |
| Self-reported disability scores | One year | |
| Re-hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Kritchevsky, Ph.D. | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| One year |
| Inter-current illness including cardiovascular events or falls | One year |
| Endurance | One year |
| Body composition by both DEXA and thigh CT | One year |
| Grip strength | One year |
| Leg strength | One year |
| ADL disability | One year |