NCT02074618

Brief Summary

The purpose of this study was to evaluate the effects of physiotherapy based on the practice of supervised exercise on functional capacity and life quality of patients with chronic kidney disease.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

February 25, 2014

Last Update Submit

March 14, 2014

Conditions

Keywords

Physical Therapy.Exercise.Rehabilitation.Renal Insufficiency.Quality of life.

Outcome Measures

Primary Outcomes (2)

  • Effect of physiotherapy on distance obtained with six-minute walk test as a measurement of functional capacity in patients with chronic kidney disease.

    Six-minute walk test is a measurement of functional capacity, which was carried out following the recommendations from the American Thoracic Society. This test has already been used in patients with chronic kidney disease in different studies found in literature.

    Six weeks.

  • Effect of physiotherapy on number of repetitions obtained with sit-to-stand test as a measurement of functional capacity in patients with chronic kidney disease.

    Sit-to-stand test is test initially described as a measure of strength of lower extremity, it is currently also considered a balancing test and has already been validated in patients with chronic kidney disease.

    Six weeks.

Secondary Outcomes (1)

  • Effect of physiotherapy on life quality of patients with chronic kidney disease.

    Six weeks.

Study Arms (1)

Physical Exercise

EXPERIMENTAL

The program of physical exercise was a resistance and aerobic training, initiated at low intensity and with a slow progressing according to the patient's tolerance. In aerobic exercise, for greater effectiveness of the training, the literature recommends moderate intensity, which corresponds with 50 to 70% of the maximum heart rate. Patients were instructed to keep the most constant as possible the speed during exercise on treadmill or cycle ergometer. For muscle strengthening exercises, the number of repetitions varied from 1 to 4 sets of 10 to 15 repetitions.

Other: Physical exercise.

Interventions

Physical exercises were held three times a week on alternate days to hemodialysis sessions, with duration of 45 to 90 minute, supervised by a physiotherapist. In all the sessions the following measurements were performed: body weight and blood pressure, heart rate and peripheral oxygen saturation in the pre, during and post session. The exercises were: heating and stretching during 5 minutes, followed by aerobic physical exercise on treadmill and/or bike (about 30 minutes), muscle strengthening exercises (15 to 20 minutes), cooling and stretching (5 minutes). The time for aerobic and strengthening varied according to the tolerance of the patient. The resistance exercises have been conducted for the major muscle groups of the lower limbs.

Physical Exercise

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be age over 18 years.
  • To make part of the hospital's hemodialysis program.
  • To receive medical prescription for practice of physical activity and sign an informed consent.

You may not qualify if:

  • Recent myocardial infarction.
  • Uncontrolled arrhythmias.
  • Uncontrolled hypertension (systolic blood pressure \> 200mmHg and diastolic blood pressure \> 120mmHg).
  • Unstable angina.
  • Severe decompensate diabetes (blood glucose \> 300 mg/dL).
  • Left ventricle dysfunction.
  • Presence of neurological or motor dysfunction that was impeditive for implementation of the protocol of physical activity.
  • Tumor.
  • Pregnancy.
  • Stopping treatment in the first 6 weeks for more than 3 consecutive sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, ChronicMotor ActivityRenal Insufficiency

Interventions

Exercise

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Georgia M Tomich, Master

    Hospital Regional Publico do Araguaia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
1- Physiotherapist, Master in Rehabilitation Sciences, Coordinator of the Center for Study and Research of the Hospital Regional Publico do Araguaia, Redenção, PA, Brazil

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 28, 2014

Study Start

May 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

March 17, 2014

Record last verified: 2014-03