Combined Resistance and Aerobic Exercise is Better Than Resistance Training Alone to Improve Functional Performance of Hemodialysis Patients - Results of a Randomized Trial

End Stage Renal Disease Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076881
• Other study ID #: UCPelotas01
• Status: Completed
• Phase: N/A
• First received: February 17, 2010
• Last updated: February 25, 2010
• Start date: December 2008
• Est. completion date: March 2009

Study information

• Verified date: February 2010
• Source: Universidade Católica de Pelotas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Behavioral:
• exercise training

Locations

Country	Name	City	State
Brazil	Hospital Universitário São Francisco de Paula	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Católica de Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical performance		10 weeks	No
Secondary	dialysis adequacy (KtV)		4/8/10 weeks	No