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Chronic Kidney Disease.NCT02074618

Physiotherapy in Patients With Chronic Kidney Disease

A study testing Physical exercise. in people with Chronic Kidney Disease., run by Hospital Regional Publico do Araguaia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Kidney Disease.
What is being tested?
Physical exercise.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
No sites listed yet
Study dates
May 2011to May 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

About this study

Official title: Impact of Physical Therapy on Functional Capacity and Quality of Patients With Chronic Kidney Disease

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.

Read the detailed description

This quasi-experimental study, with repeated measures design, was held in the ambulatory of physical therapy, in a public hospital, which serves 15 cities in the South and Southeast of the state of Pará (Brazil) and has structure of hemodialysis, outpatient, wards and intensive care units.

For inclusion in the study, the patient should have age over 18 years, make part of the hospital's hemodialysis program, receive medical prescription for practice of physical activity, and sign an informed consent. The present study was carried out in accordance with National Health Council Resolution nº 196/96 of the Brazilian Ministry of Health, and approved by the Research Ethics Committee of the Tropical Medicine Foundation of Tocantins (protocol No. 023/2011).

Contraindications to physical activity practice were considered exclusion criteria: 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. Other exclusion criteria were: tumor; pregnancy; stopping treatment in the first 6 weeks for more than 3 consecutive sessions.

At the beginning of each exercise session, if the patient had any symptoms that prevented the exercises performance, it was canceled. After the start of the session, break criteria were considered: the account of intense physical tiredness, chest pain, dizziness, paleness, syncope, pre-syncope, dyspnea disproportionate to the intensity of the effort, arrhythmia and hypotension or hypertensive response. When any of these symptoms was detected, the patient was transferred to hemodialysis service for medical evaluation.

The data were analyzed in the program Statistical Package for the Social Sciences (SPSS) version 20.0 for Windows and are expressed as mean ± standard deviation. The Wilcoxon test was used for comparison of the averages of the values obtained at the beginning of the program and in reevaluation after six weeks. In all analyses, a statistical significance level of 0.05 was considered.

Initially, an interview was conducted with the patient, to collect data as the previous and current history, co-morbidities, medications, postural changes, vital signs. In the initial contact and after six weeks, in addition to anthropometric data, the following evaluations were carried out in order to assess the effects of the exercise protocol:

  • Six-minute walk test (6MWT): 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; Reboredo et al. found a strong correlation between the distance obtained in 6MWT and peak oxygen consumption, suggesting that this test is a simple and inexpensive alternative for assessing the functional capacity of patients with chronic kidney disease who are undergoing hemodialysis treatment.
  • Sit-to-stand test: 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.
  • Quality of life assessment: the generic questionnaire Short-form 36 (SF36), translated into Portuguese was used for evaluation of life quality. Johansen et al. considered that the physical component of the SF36 is valid to assess physical performance in patients with chronic kidney disease on hemodialysis. Other authors such as Bohlke et al. and Arenas et al. used this test in patients with chronic kidney disease.

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. All these activities were performed under the supervision and guidance of a physiotherapist responsible for research. The session had total duration of about 60 minutes - 5 minutes for the daily assessment of the patient, and the 55 minutes remaining divided among the exercises.

The program of resistance and aerobic training was 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 and the score of Borg scale around. These were the criteria considered in this study. 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.

The exercises were held three times a week on alternate days to hemodialysis sessions. According to the literature, it is recommend at least three weekly sessions of 45 to 90 minute supervised exercises.

The equipment for carrying out the exercises and evaluations were blood pressure device, stethoscope, pulse oximeter, treadmill, cycle ergometry, mats, pillows, lingbar, dumbbells, elastic bands (Theraband ®), shin pads, therapeutic balls, chairs, two steps stairs.

Data collection was performed by only one physiotherapist. After the end of the period of data collection, the patients remained in rehabilitation service to continue the practice of physical activity.

Being tested
Physical exercise.
Keywords
Physical Therapy., Exercise., Rehabilitation., Renal Insufficiency., Quality of life.
Medical subject headings
Renal Insufficiency, Chronic, Motor Activity, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exercise.Other

    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.

Study groups in NCT02074618
Study groupRoleWhat they receive
Physical ExerciseExperimentalThe 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.
Receives: Other: Physical exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Six weeks.

  2. 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.

    Measured: Six weeks.

Secondary outcomes (1)
  1. Effect of physiotherapy on life quality of patients with chronic kidney disease.

    Short-form 36 (SF36) is a generic questionnaire, translated into Portuguese was used for evaluation of life quality and already used in patients with chronic kidney disease on hemodialysis.

    Measured: Six weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2014 (estimated)
  2. Study startMay 2011
  3. Primary completionApr 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02074618
Sponsor's protocol ID
GMT2013
Status last verified
Mar 2014
First submitted
25 Feb 2014
Last updated
17 Mar 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise. in people with Chronic Kidney Disease., run by Hospital Regional Publico do Araguaia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of physiotherapy on distance obtained with six-minute walk test as a measurement of functional capacity in patients with chronic kidney disease. (time frame: Six weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.

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