Combined Resistance and Aerobic Exercise is Better Than Resistance Training Alone to Improve Functional Performance of Hemodialysis Patients - Results of a Randomized Trial
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 17, 2010
CompletedFirst Posted
Study publicly available on registry
February 26, 2010
CompletedFebruary 26, 2010
February 1, 2010
3 months
February 17, 2010
February 25, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
physical performance
10 weeks
Secondary Outcomes (1)
dialysis adequacy (KtV)
4/8/10 weeks
Study Arms (2)
combined aerobic and resistance training
EXPERIMENTALresistance training alone
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitário São Francisco de Paula
Pelotas, Rio Grande do Sul, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 17, 2010
First Posted
February 26, 2010
Study Start
December 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
February 26, 2010
Record last verified: 2010-02