Effects of Combination Exercise on Fatigability in Veterans With Chronic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT04397159|
Recruitment Status : Not yet recruiting
First Posted : May 21, 2020
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Predialysis||Behavioral: Combination Exercise||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Flywheel Resistance Plus Aerobic Exercise|
|Masking:||None (Open Label)|
|Official Title:||Objective and Subjective Measures of Fatigability in Veterans With Chronic Kidney Disease Before and After Flywheel Resistance Plus Aerobic Exercise|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||October 1, 2025|
|Estimated Study Completion Date :||October 1, 2025|
Experimental: Combination Exercise
Flywheel resistance exercise plus aerobic exercise
Behavioral: Combination Exercise
Flywheel Resistance Plus Aerobic Exercise
Other Name: Flywheel Resistance Plus Aerobic Exercise
No Intervention: Standard-of-care
Participants will maintain standard-of-care and current activity levels during the course of the study.
- change in knee extensor fatigability [ Time Frame: week 6 and 12 ]Knee extensor fatigability will be assessed as changes in torque of the dominant leg during 30 contractions.
- change in perceived fatigability [ Time Frame: week 6 and 12 ]Rating of perceived fatigability will be assessed using a 10-point scale with 0 indicating "not fatigued at all" and 10 indicating "absolutely exhausted". Low scores reflect lower perceived fatigability.
- change in muscle oxygenation [ Time Frame: week 6 and 12 ]Muscle oxygenation of the vastus lateralis will be assessed using near-infrared spectroscopy and determined as the change in oxygenated hemo-myoglobin during repeated occlusion test.
- change in muscle Quality [ Time Frame: week 12 ]Muscle quality of the vastus lateralis will be assessed using diagnostic ultrasound and determined using grayscale analysis.
- change in Sit-to-Stand [ Time Frame: week 12 ]Sit-to-stand test will be used to assess physical function and determined as the time taken to complete five sit-to-stand repetitions.
- change in rate of torque development [ Time Frame: week 12 ]Rate of torque development will be calculated as the change in torque over the change in time during isometric knee extensions.
- change in muscle activation [ Time Frame: week 12 ]Muscle activation of the vastus lateralis will be determined using electromyography as the root mean square during isometric knee extensions.
- change in interleukin 6 (IL-6) and tumor necrosis factor alpha [ Time Frame: week 12 ]Interleukin 6 (IL-6) (pg/ml) and tumor necrosis factor alpha (pg/ml) will be assessed from blood samples.
- change in health-related quality of life [ Time Frame: week 12 ]Health-related quality of life will be assessed using the Short-form 36
- change in high density c-reactive protein [ Time Frame: week 12 ]Change in high density c-reactive protein (mg/L) will be assessed from blood samples.
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): NCT04397159
|Contact: Jared M Gollie, PhD||(202) 745-8000||Jared.Gollie@va.gov|
|United States, District of Columbia|
|Washington DC VA Medical Center, Washington, DC|
|Washington, District of Columbia, United States, 20422|
|Contact: Jared M Gollie, PhD 202-745-8000 Jared.Gollie@va.gov|
|Principal Investigator: Jared M. Gollie, PhD|
|Principal Investigator:||Jared M. Gollie, PhD||Washington DC VA Medical Center, Washington, DC|