Effects of Resistance Training on Physical Activity in Daily Life and Functional Capacity in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a supervised resistance exercise training during hemodialysis is effective to increase physical activity in daily life in patients with end stage renal disease.

Detailed Description
-----------------
The patients will be randomized into two groups: intervention and control groups. Patients in the intervention group will receive a supervised resistance exercise training, during hemodialysis, three times/week for 12 weeks, and patients allocate to the control group will received a passive stretching program during the same timeframe.

Official Title
-----------------
Effects of Resistance Training on Physical Activity in Daily Life, Muscle Function and Functional Capacity in Patients With End Stage Renal Disease on Hemodialysis: a Randomised Controlled Trial

Conditions
-----------------
Renal Insufficiency, Chronic

Intervention / Treatment
-----------------
* Other: Resistance Exercise Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with end stage renal disease on hemodialysis for at least three months Sedentary for at least six months Exclusion Criteria: Presence of physical limitations that prevent the implementation of physical tests Presence of severe comorbidity and unstable (unstable angina, decompensated heart failure, myocardial infarction history of the past six months, cardiac arrhythmias, uncontrolled hypertension with systolic blood pressure ≥ 200 mmHg and / or diastolic blood pressure ≥ 120 mmHg, diabetes decompensated, severe lung disease, acute systemic infection as well as neurological disorders, musculoskeletal and osteoarticular or other disabling conditions according to the clinical judgment) Hospitalization in the three months prior to study entry

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance Exercise Program<br>Patients included in intervention group will submit to resistance exercise training during hemodialysis, three times a week, for twelve weeks. This program includes exercises for the upper and lower limbs. | Other: Resistance Exercise Program<br>* During the first week of training will be conducted two sets of 10 repetitions, and from the second week of training until the twelfth will be performed three sets of 10 repetitions. The work rate will set to the tolerance of each patient as established by his/her inability to maintain Borg ratings for dyspnea and effort (10-point category-ratio Borg scale) scores between 4 and 6.<br>|
| No Intervention: Passive Stretching Program<br>Patients included in control group will submit to passive stretching program of lower limbs, during hemodialysis, three times a week, for twelve weeks. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity in Daily Life | The physical activity in daily life will be estimated as the mean number of steps using a triaxial accelerometer. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle function | The muscle function will be assessed by electromyography. | 12 weeks | 
| Muscle strength | The measurement of maximal voluntary strength of handgrip will be assessed by hydraulic model of dynamometer. | 12 weeks | 
| Functional capacity | The functional capacity will be assessed by six-minute walking test. | 12 weeks | 
| Quality of life | The quality of life will be assessed by the 36-Item Short Form Health Survey (SF36). | 12 weeks | 
| Depression and anxiety | Depression and anxiety will be assessed by the Hospital Anxiety and Depression Scale. | 12 weeks |