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Clinical Trials/NCT02775305
NCT02775305
Unknown
Not Applicable

The Effects of Frailty on Chronic Kidney Disease

San Francisco Veterans Affairs Medical Center1 site in 1 country50 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
San Francisco Veterans Affairs Medical Center
Enrollment
50
Locations
1
Primary Endpoint
Physical Function
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
San Francisco Veterans Affairs Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Cynthia Delgado

Staff Physician

San Francisco Veterans Affairs Medical Center

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

Outcomes

Primary Outcomes

Physical Function

Time Frame: baseline and 6 months

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.

Pedometer Step Count

Time Frame: Change from baseline step count to 6 months

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.

Study Sites (1)

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