The Effects of Frailty on Chronic Kidney Disease

NCT ID: NCT02775305

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-05-31

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.

Conditions

Sarcopenia; Chronic Kidney Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Frail

Intervention Type: BEHAVIORAL

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.

Interventions

Frail

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Cynthia Delgado

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia Delgado, MD

Role: PRINCIPAL_INVESTIGATOR

US Department of Veterans Affairs

Locations

Department of Veterans' Affairs Medical Center, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

IK2CX000527

Identifier Type: NIH

Identifier Source: org_study_id

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