The current study was conducted with the aim of specifying the effect of intradialytic physical and mental exercises on the quality of dialysis and fatigue in hemodialytic patients. In a controlled trial, 66 hemodialytic patients were selected via Purposive sampling, then, divided into two groups of control and experimental. The criteria for inclusion in the study involved patients’ undergoing hemodialysis 3 times a week who at least three months had passed since the start of hemodialysis, and not participating in the regular exercise program in the past 6 months; and The exclusion criteria involved reluctance to continue participating in the exercises, kidney transplant, or the patient’s death.
The experimental group was subjected to planned intradialytic training twice a week for 2 months by a senior expert in physical education. Their fatigue was measured via a fatigue severity scale questionnaire, and dialysis adequacy was measured using Kt/v formula before, one month after, and two months after intervention in both groups and then compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061112509N2
Registration date:2013-09-10, 1392/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-10, 1392/06/19
Registrant information
Name
Batool Nehrir
Name of organization / entity
Baqyatallah Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 21222899413
Email address
rnehrir1739@yahoo.com
Recruitment status
Recruitment complete
Funding source
Nephrology and Urology Research Center have paid for funding this research.
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of planned physical and mental exercises during hemodialysis on adequacy of dialysis and fatigue in hemodialysis patients
Public title
The effect of physical and mental exercises during dialysis on adequacy of dialysis and fatigue in dialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:Patients’ undergoing hemodialysis 3 times a week who at least three months had passed since the start of hemodialysis; Not participating in the regular exercise program in the past 6 months; Being capable of learning during the exercises; Having no medical prohibition for the exercise; Having no record of ischemic heart disease according to the case history; Having no record of 3rd degree congestive heart failure; No record of unstable angina.
exclusion criteria: High blood pressure over 180.110 mmHg, low blood pressure equal to 90 mmHg; Reluctance to continue participating in the exercises; Kidney transplant; Death
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Nursing
Street address
Faculty of Nursing, Building of Velayat, Street of bedside to the Artesh Square, The Northern End of the Emam Ali Highway, Tehran, Iran.
City
Tehran
Postal code
1956837172
Approval date
2012-12-26, 1391/10/06
Ethics committee reference number
32
Health conditions studied
1
Description of health condition studied
CKD(ESRD)
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Fatigue
Timepoint
before, one month after intervention, two months after intervention
Method of measurement
Fatigue Severity Scale
2
Description
adequacy of dialysis
Timepoint
before, one month after intervention, two months after intervention
Method of measurement
Kt/v formula
Secondary outcomes
1
Description
Sleep
Timepoint
before, one month after intervention, two months after intervention
Method of measurement
Pittsburgh questionnaire
2
Description
stress
Timepoint
before, one month after intervention , two months after intervention
Method of measurement
DASS questionnaire
3
Description
anxiety
Timepoint
before, one month after intervention , two months after intervention
Method of measurement
DASS questionnaire
4
Description
depression
Timepoint
before, one month after intervention , two months after intervention
Method of measurement
DASS questionnaire
Intervention groups
1
Description
The amount of urea and the weight were measured prior to hemodialysis through arteriovenous sampling. At the end of hemodialysis and before disconnecting the patient from the machine, an arterial blood sample was once more prepared from the dialyzer. In the end, patients' weight was monitored again and samples were transferred to the Laboratory.
The dialysis adequacy for both groups was measured before, 1 month after, and 2 months after the intervention and then compared, also fatigue in patients was measured via a fatigue severity scale questionnaire before, one month after, and two months after intervention and then compared.
Each patient was initially questioned about their kinetic limitations and comorbid diseases so as to propose an exercise program corresponding to their individual capabilities. The exercises were given by a senior expert in physical education during the dialysis half an hour after the patients were connected to the machine. At the beginning of each session, the trainer began taking about the system of the universe, the infinite power of God Almighty and positive thinking about the self. Then, the patients were encouraged to do stretching and flexibility movements. For the limb inflicted with fistula, the patient was told to close their eyes and imagine moving it. During the exercise intervals the patients were required to take a deep breath or do diaphragm breathing with inhalation and exhalation. Ultimately, they were taught to do relaxation exercises under the trainer’s guidance, while a soft music without lyrics was being played. In the next sessions the exercises were extended with respect to the subjects’ capabilities in terms of severity and repetition. They were continued twice a week for almost two months with a maximum time of 20 minutes.
Category
Prevention
2
Description
The control group did not receive any intervention. The amount of urea and the weight were measured prior to hemodialysis through arteriovenous sampling. At the end of hemodialysis and before disconnecting the patient from the machine, an arterial blood sample was once more prepared from the dialyzer. In the end, patients' weight was monitored again and samples were transferred to the Laboratory. The dialysis adequacy for both groups was measured before, 1 month after, and 2 months after the study and then compared, also fatigue in patients was measured via a fatigue severity scale questionnaire before, one month after, and two months after study and then compared.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiatollah Hospital
Full name of responsible person
Batool Nehrir(Instructor,PHD student of Nursing Education)