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

Renal Insufficiency, Chronic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02651025
• Other study ID #: CAAE:44426115.0.0000.5147
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2016
• Last updated: January 7, 2016
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: January 2016
• Source: Federal University of Juiz de Fora
• Contact: Felipe M Valle
• Phone: 5532988579609
• Email: felipemartins.valle[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• Resistance Exercise Program
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".

Locations

Country	Name	City	State
Brazil	University Hospital of the Federal University of Juiz de Fora	Juiz de Fora	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Juiz de Fora

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Muscle function	The muscle function will be assessed by electromyography.	12 weeks	No
Secondary	Muscle strength	The measurement of maximal voluntary strength of handgrip will be assessed by hydraulic model of dynamometer.	12 weeks	No
Secondary	Functional capacity	The functional capacity will be assessed by six-minute walking test.	12 weeks	No
Secondary	Quality of life	The quality of life will be assessed by the 36-Item Short Form Health Survey (SF36).	12 weeks	No
Secondary	Depression and anxiety	Depression and anxiety will be assessed by the Hospital Anxiety and Depression Scale.	12 weeks	No