Clinical trial NCT02651025: Effects of Resistance Training on Physical Activity in Daily Life and Functional Capacity in Hemodialysis Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Physical Activity in Daily Life
timeFrame: 12 weeks
Secondary outcomes:
measure: Muscle function
timeFrame: 12 weeks
measure: Muscle strength
timeFrame: 12 weeks
measure: Functional capacity
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
measure: Depression and anxiety
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Juiz de Fora
country: Brazil
facility: University Hospital of the Federal University of Juiz de Fora
state: Minas Gerais
Study officials:
affiliation: Federal University of Juiz de Fora
name: Maycon M Reboredo, DSc
role: STUDY_DIRECTOR
affiliation: Federal University of Juiz de Fora
name: Felipe M Valle
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Juiz de Fora
name: Bruno V Pinheiro, DSc
role: STUDY_DIRECTOR
References:
citation: Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.