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The Effects of Frailty on Chronic Kidney Disease

Primary Purpose

Sarcopenia, Chronic Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Frail
Sponsored by
San Francisco Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Veterans' Affairs Medical Center, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Not frail

Frail

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pedometer Step Count
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.
Physical Function
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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2014
Last Updated
May 16, 2016
Sponsor
San Francisco Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02775305
Brief Title
The Effects of Frailty on Chronic Kidney Disease
Official Title
The Effects of Frailty on Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Francisco Veterans Affairs Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Frailty is a syndrome characterized by decreased reserve and diminished resistance to stressors. The proposed research will evaluate the association of frailty with chronic kidney disease (CKD). The prevalence of frailty increases with age and with CKD, but studies are needed to determine whether frailty is associated with worsening of CKD and whether intervention to treat frailty can improve physical functioning and health-related quality of life (HRQOL) as well as slow progression of CKD.
Detailed Description
The intervention is a 6-month prospective interventional pilot study targeted to each domain of frailty. Subjects will be screened into the study by testing each domain; only those who meet criteria for frailty will be included in the study. The clinical intervention, which all subjects will receive, will begin immediately upon enrollment and completion of baseline measurements. Upon enrollment the 3 most recent previous outpatient serum creatinine measurements (up to 1 year) will be used to determine baseline slope of estimated glomerular filtration rate (eGFR). The main objectives of the pilot study will be to gain knowledge in the successful implementation and completion of an intervention targeted toward frailty. Ultimately information ascertained from this pilot will serve as a springboard for planning of a randomized trial aimed at addressing all the domains of frailty, which is key given that previous studies have only implemented interventions aimed at a single domain or in pairs, but no studies have evaluated the extent to which frailty can be reversed through a cohesive intervention addressing all domains together. The intervention outlined in this proposal is comprehensive and focused while maintaining feasibility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Not frail
Arm Type
No Intervention
Arm Description
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.
Arm Title
Frail
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Frail
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pedometer Step Count
Description
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.
Time Frame
Change from baseline step count to 6 months
Title
Physical Function
Description
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.
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Delgado, MD
Organizational Affiliation
US Department of Veterans Affairs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Veterans' Affairs Medical Center, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available.

Learn more about this trial

The Effects of Frailty on Chronic Kidney Disease

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