NCT01076881

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
Last Updated

February 26, 2010

Status Verified

February 1, 2010

Enrollment Period

3 months

First QC Date

February 17, 2010

Last Update Submit

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

EXPERIMENTAL
Behavioral: exercise training

resistance training alone

ACTIVE COMPARATOR
Behavioral: exercise training

Interventions

combined aerobic and resistance trainingresistance training alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

Locations