- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02775305
The Effects of Frailty on Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94121
- Department of Veterans' Affairs Medical Center, San Francisco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic Kidney Disease Stage III to IV
- Receiving care at the San Francisco Veterans Affairs Medical Center
- Able to consent in English
Exclusion Criteria:
- Early chronic kidney disease
- individuals with acute kidney injury
- non-ambulatory
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Not frail
Source of these participants will be the same as those who screen into the study; patients with chronic kidney disease receiving care at the San Francisco Veteran Affairs Medical Center.
Based on initial screening if participants do not meet criteria for frailty, baseline screening data will be used for comparative analysis as the no intervention arm.
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Experimental: Frail
Source of these participants will be the same as those who screen into the study; patients with chronic kidney disease receiving care at the San Francisco Veteran Affairs Medical Center.
Based on initial screening if participants meet criteria for frailty participants will be enrolled in the intervention arm.
Participants who are ambulatory regardless of co-morbidities will not be excluded from the study.
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Slowness/weakness: Physical therapy(PT) strength and gait training. A standardized strengthening program will be prescribed, to be performed at home. Additional in-person PT training will be provided to those who are severely deconditioned . Weight loss/malnutrition: A licensed nutritionist specializing in kidney disease will meet with participants for 3 one-hour one-on-one nutritional counseling. Low physical activity: Participants will receive individualized walking recommendations using a pedometer. Walking activity will be assessed weekly, and new goals for increasing steps in the following week will be set. Exhaustion: Those who meet criteria for severe depression using the center for epidemiologic studies depression (CES-D) scale will be immediately referred to psychiatry for counseling for patient safety. All others will participate in cognitive behavioral coping techniques. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pedometer Step Count
Time Frame: Change from baseline step count to 6 months
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The number of steps achieved over the 6 month period will be assessed.
Pedometer data is collected each week.
Based on the weekly achieved counts a new goal is generated for each participant.
This assessment will include study investigators collecting step count logs from the participant on a weekly basis.
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Change from baseline step count to 6 months
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Physical Function
Time Frame: baseline and 6 months
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Change in physical functioning will be assessed using the short physical performance battery (SPPB).
Investigators will compare baseline Short physical performance battery (SPPB) score to 6 month score to determine change in functioning as a result of the intervention.
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baseline and 6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Cynthia Delgado, MD, US Department of Veterans Affairs
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IK2CX000527 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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