- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02074618
Physiotherapy in Patients With Chronic Kidney Disease
Impact of Physical Therapy on Functional Capacity and Quality of Patients With Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
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.
- Tumor.
- Pregnancy.
- Stopping treatment in the first 6 weeks for more than 3 consecutive sessions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Physical Exercise
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
Time Frame: Six weeks.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of physiotherapy on life quality of patients with chronic kidney disease.
Time Frame: Six weeks.
|
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.
|
Six weeks.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Georgia M Tomich, Master, Hospital Regional Publico do Araguaia
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMT2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Kidney Disease.
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
Centre Hospitalier le MansLe Mans UniversiteWithdrawnFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage3 | Chronic Kidney Failure | Chronic Kidney Disease, Stage 4 (Severe)
-
Centre Hospitalier le MansLe Mans UniversiteRecruitingFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage 3BFrance
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
Lund UniversityBaxter Healthcare Corporation; Universidad de CórdobaCompletedEnd Stage Kidney Disease | Chronic Kidney Disease Requiring Chronic DialysisArgentina
-
Centre Hospitalier Saint Joseph Saint Luc de LyonNot yet recruitingKidney Failure, Chronic | Diet Habit | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 3B | Chronic Kidney Disease, Stage 3 (Moderate) | Chronic Kidney Disease Stage 3A (Disorder)France
-
A.C. AbrahamsCompletedEnd Stage Renal Disease | Chronic Kidney Disease | End Stage Kidney Disease | Chronic Kidney FailureNetherlands
-
Far Eastern Memorial HospitalActive, not recruitingMetabolic Syndrome | Chronic Disease | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease Stage 3 | Chronic Kidney Disease Stage 4 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
Clinical Trials on Physical exercise.
-
Universidade Estadual da ParaibaUniversity of Campinas, BrazilUnknown
-
Clarice Maria de Lucena MartinsCompletedMetabolic Diseases | Physical Activity
-
Instituto de Cardiologia do Rio Grande do SulFundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, BrazilTerminatedObesity | Sedentary Lifestyle | Hypercholesterolemia | High Blood PressureBrazil
-
Universidad Católica San Antonio de MurciaCompleted
-
Cardiff UniversityCompletedParkinson's DiseaseUnited Kingdom
-
Instituto Materno Infantil Prof. Fernando FigueiraCompleted
-
Mathieu RoyUniversité du Québec à Trois-Rivières; Université de Montréal; Concordia University... and other collaboratorsCompleted
-
National Research Centre for the Working Environment...CompletedMusculoskeletal DisordersDenmark
-
Bioaraba Health Research InstituteRecruitingStress, Psychological | AnxietySpain
-
Göteborg UniversityVastra Gotaland Region; Sahlgrenska University Hospital, SwedenCompletedChronic Widespread PainSweden