The Effects of Frailty on Chronic Kidney Disease

NCT02775305 | Unknown

• 1 other identifier: IK2CX000527
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline step count to 6 months

• 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.

  baseline and 6 months

Study Arms (2)

Not frail

NO INTERVENTION

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.

Frail

EXPERIMENTAL

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.

Behavioral: Frail

Interventions

Frail 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.

Frail

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Kidney Disease Stage III to IV
• Receiving care at the San Francisco Veterans Affairs Medical Center
• Able to consent in English

You may not qualify if:

• Early chronic kidney disease
• individuals with acute kidney injury
• non-ambulatory

Sponsors & Collaborators

• San Francisco Veterans Affairs Medical Center: lead

Study Sites (1)

Department of Veterans' Affairs Medical Center, San Francisco

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Sarcopenia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Cynthia Delgado, MD

  US Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: May 17, 2016
• Study Start: October 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 17, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)