An interventional study of Exercise training and Usual Care in Chronic Kidney Disease, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
The majority of individuals with advanced ESRD have reduced exercise capacity in part due to decreased muscle mass. This leads to a reduced ability to perform daily activities, a greater incidence of falls, and a reduced quality of life. The mechanisms responsible for the loss of muscle mass in ESRD are not understood very well. This study is designed to determine the effectiveness of an exercise program on improving muscle mass, exercise capacity and quality of life in persons with ESRD. In addition, the study will attempt to better understand why muscle loss occurs in people with ESRD, the influence exercise has on these mechanisms, and whether the response to exercise can be enhanced with nutrient supplementation.
Elderly patients comprising half the end-stage renal disease (ESRD) population, are especially vulnerable to loss of muscle mass, strength and function, changes that lead to frailty and increased morbidity and mortality. Many factors contribute to the decline in muscle mass and function in the elderly uremic and apart from aging and co-morbid conditions, wasting is worsened by inactivity. Studies in maintenance hemodialysis (MHD) patients have shown that exercise (EX), including endurance, resistance or combined, can counteract the loss of muscle mass and function. However most studies have not specifically targeted the elderly, involved small numbers or lacked controls and the impact on long-term outcome is unknown. Nevertheless, despite substantial evidence indicating that EX is beneficial and low cost, EX is not part of the routine care of MHD patients. In contrast EX is regarded as standard of care for the wasted elderly and also cardiac patients. Some protection against uremic muscle wasting can also be afforded by an adequate protein-calorie intake. Amino acids (AA) from this source serve as substrates for protein synthesis (PS) and also directly activate the mTOR signaling pathway stimulating PS. In normal subjects if AA are ingested at the time of resistance EX, anabolic signaling and PS is enhanced and this leads to increases in muscle mass. Whether the EX and AA stimulated signaling response is intact in elderly MHD patients is unknown and there is little information about the cellular processes invoked. Taking this all together, the investigators plan to test the hypothesis that a home-based EX program, effective in cardiac patients, will improve cardiopulmonary function and muscle mass and function in elderly MHD patients. Also, in a pilot study the investigators will examine whether a protein supplement acutely enhances EX stimulated anabolic signaling. Functionally impaired MHD subjects aged 65-80 yrs are randomized into 2 groups of 30 each, one undergoing EX and the other usual care. After 3 months, half in each group receive a one-time protein-calorie supplement or placebo during an acute bout of EX and muscle biopsied for examining the signaling response. Assays at baseline and at 3 months include cardiopulmonary function, muscle strength and function, body composition by DEXA, thigh muscle volume and composition by CT, quality of life (QOL) and cognitive function, and nutritional, inflammatory, lipid and biochemical status and morphologic and molecular analysis of biopsied muscle. The investigators anticipate that home-based EX will counteract muscle wasting, enhance cardiopulmonary and muscle function and QOL, and reduce surrogate markers of long-term outcome. New insights into the mechanisms whereby EX and nutrients induce an anabolic response in muscle of elderly uremics will be provided and may serve as a basis for devising strategies to counteract loss of muscle mass and function. Finally, the investigators anticipate that the EX program will be "user friendly" and may thus form a part of the routine care of elderly and perhaps younger MHD patients. If short-term benefits are evident from this study in elderly MHD patients, it could form the basis for a comprehensive long-term outcomes study.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 37 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
The study involves two arms randomized to exercise and usual care groups
Other: Exercise training · Other: Usual Care
This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group.
Other: Usual Care
Subjects will participate in a center-based and home exercise training program for 3 months.
This group will serve as control subjects. They will receive only usual clinical care.
Maximal Oxygen Uptake
The overall primary outcome for the study is maximal oxygen uptake. Maximal oxygen uptake is the amount of oxygen consumed by the body during maximal exercise. It is the gold standard expression for exercise capacity.
Time frame: 3 months
Biopsy of the Quadriceps Muscle.
The biopsy procedures will permit the measurement of the percentage of type 1 fibers in the quadriceps muscle. The biopsy procedures will also be used to quantify protein signaling, a measure of the capacity of the muscle to gain or lose muscle mass.
Time frame: 3 Months
Quality of Life Score
Disease-specific quality of life instrument is used to quantify broad quality of life domains, including physical function. Higher scores mean better values using a 0-100 scale.
Time frame: 3 months
| Milestone | Exercise | Usual Care |
|---|---|---|
| Started | 18 | 19 |
| Completed | 13 | 15 |
| Not completed | 5 | 4 |
| Withdrew: Physician decision | 5 | 4 |
The overall primary outcome for the study is maximal oxygen uptake. Maximal oxygen uptake is the amount of oxygen consumed by the body during maximal exercise. It is the gold standard expression for exercise capacity.
| ml/kg/min | Exercise | Usual Care |
|---|---|---|
| Maximal Oxygen Uptake | 14.5 ± 3.3 | 15.1 ± 3.3 |
The biopsy procedures will permit the measurement of the percentage of type 1 fibers in the quadriceps muscle. The biopsy procedures will also be used to quantify protein signaling, a measure of the capacity of the muscle to gain or lose muscle mass.
| Percentage of type 1 fibers | Exercise | Usual Care |
|---|---|---|
| Biopsy of the Quadriceps Muscle. | 33.2 ± 11 | 30.0 ± 9 |
Disease-specific quality of life instrument is used to quantify broad quality of life domains, including physical function. Higher scores mean better values using a 0-100 scale.
| score on a scale | Exercise | Usual Care |
|---|---|---|
| Quality of Life Score | 48.7 ± 25.6 | 60.0 ± 22.3 |
Collected over 3 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exercise | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Usual Care | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
Chronic kidney disease on maintenance hemodialysis.
| Age, Categorical(Participants) | Exercise | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 2 | 5 |
| >=65 years | 10 | 13 | 23 |
| Age, Continuous(years) | Exercise | Usual Care | Total |
|---|---|---|---|
| Mean | 66.3 ± 7.6 | 66.2 ± 6.7 | 66.3 ± 6.9 |
| Sex: Female, Male(Participants) | Exercise | Usual Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 13 | 15 | 28 |
| Ethnicity (NIH/OMB)(Participants) | Exercise | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 13 | 15 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Exercise | Usual Care | Total |
|---|---|---|---|
| United States | 13 | 15 | 28 |
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