End-stage Renal Disease
Conditions
Keywords
dialysis, end-stage renal disease
Brief summary
Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.
Interventions
BEHAVIORALpedometer
pedometer-based physical activity recommendations
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* on hemodialysis for ≥ 3 months * able to walk * able to give informed consent and willing to participate
Exclusion criteria
* unable to walk * unable to understand directions or give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | Baseline and 12 weeks | change in steps per day from pedometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Physical Functioning | Baseline and 12 weeks | Change in score on the Physical Function scale of the Short-Form 36 Health Survey (scale from 0-100, higher numbers indicate better physical functioning) |
| Change in Activities of Daily Living Score | Baseline and 12 weeks | Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence) |
| Change in Symptom Burden on the Dialysis Symptoms Index | Baseline and 12 weeks | Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced) |
| Change in Total Body Muscle Mass (Adjusted by Height Squared) | Baseline and 12 weeks | (TBMM calculated from measurements of intracellular water from bioimpedance spectrometry) |
| Physical Performance | Baseline and 12 weeks | change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance |
| Change in the Short From 36 Vitality Scale | Baseline and 12 weeks | Short Form 36 Vitality Scale (0-100, greater values indicate increased levels of energy/decreased levels of fatigue) |
| Change in SDNN (ms) | 12 weeks | Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms) |
| Change in Symptom Severity on Dialysis Symptoms Index | Baseline and 12 weeks | Symptoms range from score of 0 (Not at all bothersome) to 5 (Very Bothersome) over 29 symptoms. Score ranges from 0 - 145 |
| Change in Endothelial Function | 12 weeks | Reactive hyperemia index (RHI) using peripheral arterial tonometry. RHI is a non-invasive measure of endothelial function, measured using the EndoPAT 2000 (Itamar Medical). The pulse amplitude in the middle fingers of both hands was recorded for five minutes. A blood pressure cuff was then inflated in one arm (which did not have a vascular access in place) to at least 60 mmHg above systolic blood pressure to achieve full occlusion (minimum 200 mmHg, maximum 300 mmHg). After occlusion for 5 minutes, the cuff was deflated, and the device recorded changes in pulse amplitude for an additional 5 minutes and calculated RHI as the ratio of the post to pre occlusion amplitude of the occluded arm relative to the post to pre occlusion amplitude of the control arm, corrected for baseline vascular tone. |
Countries
United States
Participant flow
Recruitment details
Patients recruited from 3 local San Francisco dialysis clinics
Pre-assignment details
Baseline assessment performed prior to random assignment
Participants by arm
| Arm | Count |
|---|---|
| Pedometer Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week. | 30 |
| Usual Care Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | Pedometer | Usual Care |
|---|---|---|---|
| Age, Continuous | 58 years | 60 years | 56 years |
| Arrhythmia | 10 Participants | 6 Participants | 4 Participants |
| BMI | 29 kg/m^2 | 26.9 kg/m^2 | 31.6 kg/m^2 |
| Congestive Heart Failure | 17 Participants | 9 Participants | 8 Participants |
| Coronary Artery Disease | 19 Participants | 11 Participants | 8 Participants |
| Currently smoking | 9 Participants | 6 Participants | 3 Participants |
| Diabetes | 22 Participants | 10 Participants | 12 Participants |
| Dialysis Vintage (Years) | 3.1 years | 3.7 years | 1.9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 23 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants |
| Hemoglobin | 10.7 mg/dL | 10.6 mg/dL | 10.9 mg/dL |
| HIV | 1 Participants | 0 Participants | 1 Participants |
| Hypertension | 56 Participants | 28 Participants | 28 Participants |
| Peripheral Vascular Disease | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 14 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 9 Participants | 4 Participants | 5 Participants |
| Region of Enrollment United States | 60 Participants | 30 Participants | 30 Participants |
| Serum Albumin | 3.9 g/dL | 3.9 g/dL | 3.9 g/dL |
| Sex: Female, Male Female | 13 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 47 Participants | 28 Participants | 19 Participants |
| Standardized Kt/V | 2.32 unitless, per week | 2.30 unitless, per week | 2.37 unitless, per week |
| Stroke | 6 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 30 | 0 / 30 |
| other Total, other adverse events | 6 / 30 | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Physical Activity
change in steps per day from pedometer
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pedometer | Physical Activity | 1474 steps/day |
| Usual Care | Physical Activity | 180 steps/day |
p-value: <0.01linear mixed modeling
Secondary
Change in Activities of Daily Living Score
Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence)
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pedometer | Change in Activities of Daily Living Score | 0 score on a scale |
| Usual Care | Change in Activities of Daily Living Score | 0 score on a scale |
Secondary
Change in Endothelial Function
Reactive hyperemia index (RHI) using peripheral arterial tonometry. RHI is a non-invasive measure of endothelial function, measured using the EndoPAT 2000 (Itamar Medical). The pulse amplitude in the middle fingers of both hands was recorded for five minutes. A blood pressure cuff was then inflated in one arm (which did not have a vascular access in place) to at least 60 mmHg above systolic blood pressure to achieve full occlusion (minimum 200 mmHg, maximum 300 mmHg). After occlusion for 5 minutes, the cuff was deflated, and the device recorded changes in pulse amplitude for an additional 5 minutes and calculated RHI as the ratio of the post to pre occlusion amplitude of the occluded arm relative to the post to pre occlusion amplitude of the control arm, corrected for baseline vascular tone.
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pedometer | Change in Endothelial Function | -0.1 unitless |
| Usual Care | Change in Endothelial Function | 0.1 unitless |
Secondary
Change in SDNN (ms)
Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pedometer | Change in SDNN (ms) | 1.54 ms |
| Usual Care | Change in SDNN (ms) | -0.13 ms |
Secondary
Change in Symptom Burden on the Dialysis Symptoms Index
Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pedometer | Change in Symptom Burden on the Dialysis Symptoms Index | 1 score on a scale |
| Usual Care | Change in Symptom Burden on the Dialysis Symptoms Index | 0 score on a scale |
Secondary
Change in Symptom Severity on Dialysis Symptoms Index
Symptoms range from score of 0 (Not at all bothersome) to 5 (Very Bothersome) over 29 symptoms. Score ranges from 0 - 145
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pedometer | Change in Symptom Severity on Dialysis Symptoms Index | 2 score on a scale |
| Usual Care | Change in Symptom Severity on Dialysis Symptoms Index | -1 score on a scale |
Secondary
Change in the Short From 36 Vitality Scale
Short Form 36 Vitality Scale (0-100, greater values indicate increased levels of energy/decreased levels of fatigue)
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pedometer | Change in the Short From 36 Vitality Scale | 0 score on a scale |
| Usual Care | Change in the Short From 36 Vitality Scale | 5 score on a scale |
Secondary
Change in Total Body Muscle Mass (Adjusted by Height Squared)
(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)
Time frame: Baseline and 12 weeks
Population: Note: we were unable to obtain body composition measures from all participants at baseline and 12 weeks (Missing data from: 3 with metal implants, 1 with pacemaker, 2 with poor quality of measurement likely related to fluid shifts)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pedometer | Change in Total Body Muscle Mass (Adjusted by Height Squared) | 0.30 kg/m2 |
| Usual Care | Change in Total Body Muscle Mass (Adjusted by Height Squared) | -0.47 kg/m2 |
Secondary
Physical Performance
change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pedometer | Physical Performance | 0 score on a scale |
| Usual Care | Physical Performance | 0 score on a scale |
Secondary
Self-reported Physical Functioning
Change in score on the Physical Function scale of the Short-Form 36 Health Survey (scale from 0-100, higher numbers indicate better physical functioning)
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pedometer | Self-reported Physical Functioning | 0 score on a scale |
| Usual Care | Self-reported Physical Functioning | 5 score on a scale |