Combined Resistance and Aerobic Exercise is Better Than Resistance Training Alone to Improve Functional Performance of Hemodialysis Patients - Results of a Randomized Trial
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
exercise training
Sponsored by
About this trial
This is an interventional supportive care trial for End Stage Renal Disease
Eligibility Criteria
Inclusion Criteria:
- to be on hemodialysis therapy for longer than 3 months
- to be already included in the resistance training protocol during dialysis
- to receive erythropoietin for the treatment of anemia
- hemoglobin level greater than 9.0 g/dL
- to be able to maintain sitting and standing balance and ambulatory without assistance.
Exclusion Criteria:
- symptomatic ischemic heart disease
- recent myocardial infarction of less than 6 months
- uncontrolled hypertension
- pericardial or pleural friction rub
- aortic stenosis
- active musculoskeletal lower-extremity problem, or history of vertebral fracture caused by osteoporosis
- patients were also excluded if they participated in formal organized exercise programs outside the dialysis unit.
Sites / Locations
- Hospital Universitário São Francisco de Paula
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
combined aerobic and resistance training
resistance training alone
Arm Description
Outcomes
Primary Outcome Measures
physical performance
Secondary Outcome Measures
dialysis adequacy (KtV)
Full Information
NCT ID
NCT01076881
First Posted
February 17, 2010
Last Updated
February 25, 2010
Sponsor
Universidade Católica de Pelotas
1. Study Identification
Unique Protocol Identification Number
NCT01076881
Brief Title
Combined Resistance and Aerobic Exercise is Better Than Resistance Training Alone to Improve Functional Performance of Hemodialysis Patients - Results of a Randomized Trial
Official Title
Combined Resistance and Aerobic Exercise is Better Than Resistance Training Alone to Improve Functional Performance of Hemodialysis Patients - Results of a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Católica de Pelotas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized trial with participants recruited from one dialysis unit of a Brazilian university hospital. Hemodialysis patients were assigned to receive the resistance exercise combined with an aerobic training or the resistance training alone for a period of 10 weeks. The functional performance of patients was assessed before and after the intervention through the six-minute walk test (6MWT). The difference over time of the 6MWT was compared between the groups through multivariate linear regression.
Thirteen patients were allocated for each group of intervention. The difference in distance walked before and after intervention in the combined training group was of +39.7 (61.4) meters, and this difference in the resistance training group was of -19.2 (53.9) meters, p=0.01. In multivariate analysis with adjustment for age, skin color, gender, hematocrit, time since starting dialysis, Kt/V and baseline values of 6MWT, the type of training remained significantly associated with the amount of increase in walked distance.
Although the best protocol of exercise for patients on dialysis is not yet clear, in the investigators sample of hemodialysis patients the combination of aerobic and resistance training was more effective to improve functional performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
combined aerobic and resistance training
Arm Type
Experimental
Arm Title
resistance training alone
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Primary Outcome Measure Information:
Title
physical performance
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
dialysis adequacy (KtV)
Time Frame
4/8/10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
to be on hemodialysis therapy for longer than 3 months
to be already included in the resistance training protocol during dialysis
to receive erythropoietin for the treatment of anemia
hemoglobin level greater than 9.0 g/dL
to be able to maintain sitting and standing balance and ambulatory without assistance.
Exclusion Criteria:
symptomatic ischemic heart disease
recent myocardial infarction of less than 6 months
uncontrolled hypertension
pericardial or pleural friction rub
aortic stenosis
active musculoskeletal lower-extremity problem, or history of vertebral fracture caused by osteoporosis
patients were also excluded if they participated in formal organized exercise programs outside the dialysis unit.
Facility Information:
Facility Name
Hospital Universitário São Francisco de Paula
City
Pelotas
State/Province
RS
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Combined Resistance and Aerobic Exercise is Better Than Resistance Training Alone to Improve Functional Performance of Hemodialysis Patients - Results of a Randomized Trial
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