The Effects of Frailty on Chronic Kidney Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02775305|
Recruitment Status : Active, not recruiting
First Posted : May 17, 2016
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sarcopenia Chronic Kidney Disease||Behavioral: Frail||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Frailty on Chronic Kidney Disease|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||May 2016|
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.
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.
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775305
|United States, California|
|Department of Veterans' Affairs Medical Center, San Francisco|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Cynthia Delgado, MD||Department of Veterans' Affairs|