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

NCT ID: NCT02621918

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-06-30

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.

Detailed Description

Subjects were randomized into group A and B: group A (n=30) exercised for the first 6 months while group B (n=31) performed a placebo exercise initially (3 months) and cross-over to aerobic exercised for 3 months more.

Conditions

End Stage Renal Failure on Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Progressive Resistance Training (PRT)

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).

Group Type: EXPERIMENTAL

Progressive resistance training

Intervention Type: OTHER

Aerobic Exercise (AER)

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.

Group Type: EXPERIMENTAL

Aerobic training

Intervention Type: OTHER

NEPLA

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.

Group Type: PLACEBO_COMPARATOR

Placebo training

Intervention Type: OTHER

Interventions

Progressive resistance training

Intervention Type: OTHER

Aerobic training

Intervention Type: OTHER

Placebo training

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Clara S C Rosa

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 35018639 (View on PubMed)

Other Identifiers

CAAE-02564112.2.0000.5423

Identifier Type: -

Identifier Source: org_study_id