Trial Outcomes & Findings for Use of Pedometers to Measure and Increase Walking Among Patients With ESRD (NCT NCT02623348)

NCT ID: NCT02623348

Last Updated: 2019-10-02

Results Overview

change in steps per day from pedometer

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2019-10-02

Participant Flow

Patients recruited from 3 local San Francisco dialysis clinics

Baseline assessment performed prior to random assignment

Participant milestones

Measure	Pedometer Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	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.
Overall Study STARTED	30	30
Overall Study 3-month Assessment	27	26
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Pedometers to Measure and Increase Walking Among Patients With ESRD

Baseline characteristics by cohort

Measure	Pedometer n=30 Participants Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=30 Participants Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.	Total n=60 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	56 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	19 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
BMI	26.9 kg/m^2 n=5 Participants	31.6 kg/m^2 n=7 Participants	29 kg/m^2 n=5 Participants
Dialysis Vintage (Years)	3.7 years n=5 Participants	1.9 years n=7 Participants	3.1 years n=5 Participants
Hemoglobin	10.6 mg/dL n=5 Participants	10.9 mg/dL n=7 Participants	10.7 mg/dL n=5 Participants
Serum Albumin	3.9 g/dL n=5 Participants	3.9 g/dL n=7 Participants	3.9 g/dL n=5 Participants
Standardized Kt/V	2.30 unitless, per week n=5 Participants	2.37 unitless, per week n=7 Participants	2.32 unitless, per week n=5 Participants
Currently smoking	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Hypertension	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Diabetes	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Coronary Artery Disease	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Congestive Heart Failure	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Stroke	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Peripheral Vascular Disease	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
HIV	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Arrhythmia	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

change in steps per day from pedometer

Outcome measures

Measure	Pedometer n=27 Participants Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=26 Participants Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
Physical Activity	1474 steps/day Interval 40.0 to 3538.0	180 steps/day Interval -650.0 to 1040.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance

Outcome measures

Measure	Pedometer n=27 Participants Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=26 Participants Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
Physical Performance	0 score on a scale Interval 0.0 to 1.0	0 score on a scale Interval -1.0 to 1.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Pedometer n=27 Participants Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=26 Participants Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
Self-reported Physical Functioning	0 score on a scale Interval -10.0 to 5.0	5 score on a scale Interval -5.0 to 10.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence)

Outcome measures

Measure	Pedometer n=27 Participants Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=26 Participants Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
Change in Activities of Daily Living Score	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)

Outcome measures

Measure	Pedometer n=27 Participants Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=26 Participants Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
Change in Symptom Burden on the Dialysis Symptoms Index	1 score on a scale Interval -1.5 to 2.0	0 score on a scale Interval -2.0 to 2.0

SECONDARY outcome

Timeframe: 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)

(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)

Outcome measures

Measure	Pedometer n=23 Participants Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=24 Participants Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
Change in Total Body Muscle Mass (Adjusted by Height Squared)	0.30 kg/m2 Interval -0.5 to 0.76	-0.47 kg/m2 Interval -0.9 to 0.35

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Pedometer n=27 Participants Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=26 Participants Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
Change in Endothelial Function	-0.1 unitless Interval -0.3 to 0.22	0.1 unitless Interval -0.57 to 0.28

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Short Form 36 Vitality Scale (0-100, greater values indicate increased levels of energy/decreased levels of fatigue)

Outcome measures

Measure	Pedometer n=27 Participants Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=26 Participants Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
Change in the Short From 36 Vitality Scale	0 score on a scale Interval -10.0 to 15.0	5 score on a scale Interval -10.0 to 10.0

SECONDARY outcome

Timeframe: 12 weeks

Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)

Outcome measures

Measure	Pedometer n=27 Participants Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=26 Participants Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
Change in SDNN (ms)	1.54 ms Interval -6.19 to 11.57	-0.13 ms Interval -6.95 to 2.27

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Pedometer n=27 Participants Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=26 Participants Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
Change in Symptom Severity on Dialysis Symptoms Index	2 score on a scale Interval -3.5 to 13.0	-1 score on a scale Interval -9.0 to 9.0

Adverse Events

Pedometer

Serious events: 0 serious events

Other events: 6 other events

Deaths: 1 deaths

Usual Care

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pedometer n=30 participants at risk Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week.	Usual Care n=30 participants at risk Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care.
General disorders Fatigue	20.0% 6/30 • Number of events 6 • 24 months total, 6 months per patient	6.7% 2/30 • Number of events 2 • 24 months total, 6 months per patient

Additional Information

Anoop Sheshadri

University of California, San Francisco

Phone: 415-221-4810

Email: anoop.sheshadri@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place