The Effects of Exercise in End-stage Renal Disease Patients Undergoing Hemodialysis

NCT02621918 | Completed DMC

• 1 other identifier: CAAE-02564112.2.0000.5423
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief Summary

We aimed to investigate the effect of a progressive resistance training and aerobic training protocol on functional capacity, body composition and quality of life.

Conditions

End Stage Renal Failure on Dialysis

Outcome Measures

Primary Outcomes (1)

• Body composition by Dual-energy x-ray absorptiometry (DEXA)

  Dual-energy x-ray absorptiometry (DEXA) was used to measure lean body mass (LBM), fat mass (FM) and Bone Mineral Contend (BMC) in grams using a total body scan, following the equipment description - HOLOGIC Discovery Wi (Hologic inc, Waltham, MA, USA). Body composition variables included in this study were total mass, body FM, LBM and legs LBM, and BMC. Body composition was assessed after a hemodialysis day; time after previous hemodialysis did not exceed eight hours.

  before and after 12 and 24 weeks of study

Secondary Outcomes (3)

• Quality of life assessed by the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)

  before and after 12 and 24 weeks of study

• Functional capacity

  before and after 12 and 24 weeks of study

• Pulmonary capacity

  before and after 12 and 24 weeks of study. Additionally this variable was assessed over the three time points before and after one hemodialysis session.

Study Arms (3)

Progressive Resistance Training (PRT)

EXPERIMENTAL

For the progressive resistance training we use 11 exercises. The exercises for upper limbs were held in the waiting room before the hemodialysis session. Resistance exercise was carried out in two sets of 15-20 repetitions, the intensity were determined by the method of maximal repetitions, where series were run until exhaustion to momentary exercises (15-20 repetitions) with specific load. The load adjustments or volume were managed when necessary, but necessarily for every 4th week of training. The effort perception should be situated between 12 and 16 on the Borg scale (Borg and Noble, 1974), as proposed by The Life Options Rehabilitation Advisory Council: Exercise for the Patient Dialysis (1995).

Other: Progressive resistance training

Aerobic Exercise (AER)

EXPERIMENTAL

Aerobic exercise was conducted with a mini ergometer cycling (Mini Bike E5 Acte Sports) attached to the patient chair. Patients exercised 50-60 minutes of continuous workout with increased load. The workload was adjusted when necessary, according to the perceived effort made by the patient. The scale of perceived exertion, Borg scale (Borg and Noble , 1974), was used in accordance with the proposed By The Life Options Rehabilitation Advisory Council: Exercise for the Patient Dialysis (1995), which defines the values of perceived exertion between 12 and 16.

Other: Aerobic training

NEPLA

PLACEBO COMPARATOR

The control group performed active mobilization of members, circumduction of cervical, scapular girdle and extremities, breathing exercises with no loads, set on three to five repetitions only and no stretch exercises. The exercises were performed during the hemodialysis session, three times per week and did not exceed 5 minutes.

Other: Placebo training

Interventions

Progressive resistance training OTHER

Progressive Resistance Training (PRT)

Aerobic training OTHER

Aerobic Exercise (AER)

Placebo training OTHER

NEPLA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years
• more than three months of hemodialysis vintage
• under the permission of their nephrologist
• agreement to be randomly assigned and undergo study protocols

You may not qualify if:

• Patients in wheelchair, presenting disability, or those who had amputation and malformation of the lower limbs, causing impaired walking
• presenting representative blindness

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Related Publications (1)

• 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.

  PMID: 35018639 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: December 4, 2015
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2014
• Last Updated: July 27, 2016

Record last verified: 2016-07