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

End-stage Renal Disease Clinical Trial

— PED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623348
• Other study ID #: 10-02719
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: June 2018

Study information

• Verified date: September 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• pedometer
pedometer-based physical activity recommendations

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	change in steps per day from pedometer	Baseline and 12 weeks
Secondary	Physical Performance	change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance	Baseline and 12 weeks
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)	Baseline and 12 weeks
Secondary	Change in Activities of Daily Living Score	Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence)	Baseline and 12 weeks
Secondary	Change in Symptom Burden on the Dialysis Symptoms Index	Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)	Baseline and 12 weeks
Secondary	Change in Total Body Muscle Mass (Adjusted by Height Squared)	(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)	Baseline and 12 weeks
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.	12 weeks
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)	Baseline and 12 weeks
Secondary	Change in SDNN (ms)	Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)	12 weeks
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	Baseline and 12 weeks