Determining the effect of the sports package of easy exercises on the dialysis adequacy index before and after the intervention
Comparison of the effect of the sports package of easy exercises on the dialysis adequacy index before and after the intervention
Determining the effect of the sports package of easy exercises on the quality of life in hemodialysis patients before and after the intervention
Comparison of the effect of the sports package of easy exercises on the quality of life in hemodialysis patients before and after the intervention
Determining the effect of the sports package of easy exercises on the quality of sleep in hemodialysis patients before and after the intervention
Comparison of the effect of the sports package of easy exercises on sleep quality in hemodialysis patients before and after the intervention
Design
intervention, with a sample size of 45 people
Settings and conduct
Easy exercise packages that include (hexagonal weight, wrist strengthening ring, pilates stretch, stretch loop) will be prepared and then referred to the dialysis department of Baqiyatollah Hospital and according to the sample size (number of 45 people) by sampling in Available subjects will be selected.
Participants/Inclusion and exclusion criteria
The subjects of the research will include 45 hemodialysis patients of the dialysis department of Baqiyat Allah Hospital, with an age range of 30 to 80 years and with a duration of dialysis of more than 1 year. Subjects with a history of certain diseases such as cardiovascular diseases, cognitive disorders, arthritis, certain diseases that prevent physical activity will be prohibited from participating in the research.
Intervention groups
A group of 45 people will do sports exercises 3 times a week during dialysis for a duration of 12 weeks.
Main outcome variables
Quality of sleep, adequacy of dialysis, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230308057656N1
Registration date:2023-04-11, 1402/01/22
Registration timing:prospective
Last update:2023-04-11, 1402/01/22
Update count:0
Registration date
2023-04-11, 1402/01/22
Registrant information
Name
Enayatalah joukar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 9212 1266
Email address
arashjoukar99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-21, 1402/03/31
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of using Easy Workout Kit on Hemodialysis outcomes
Public title
Investigating the Effect of using Easy Workout Kit on Hemodialysis outcomes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The subjects of the research will include 45 hemodialysis patients of the dialysis department of Baqiyat Allah Hospital, with an age range of 30 to 80 years and with a duration of dialysis of more than 1 year.
Exclusion criteria:
History of special diseases such as cardiovascular diseases, cognitive disorders, arthritis, special diseases that prevent a person from physical activity.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
using Easy Workout Kit
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiatallah medical of sciences University
Street address
Baqiyatallah University of Medical Sciences, No. 26, South Sheikh Bahaei St., Mollasadra Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-02-26, 1401/12/07
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.131
Health conditions studied
1
Description of health condition studied
chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Sleep quality score in Richard Campbell questionnaire
Timepoint
Before and after the intervention
Method of measurement
Richard Campbell Questionnaire
2
Description
Quality of life score with KDQOL-SFTM questionnaire
Timepoint
Before and after the intervention
Method of measurement
KDQOL-SFTM questionnaire
3
Description
Dialysis adequacy using blood biochemical tests (URR, KT/V, P, Ca, Na, K, PTH, HCo3-, and Plt)
Timepoint
Before and after the intervention
Method of measurement
Dialysis adequacy using blood biochemical tests (URR, KT/V, P, Ca, Na, K, PTH, HCo3-, and Plt)
Secondary outcomes
empty
Intervention groups
1
Description
Easy exercise packages that include (hexagonal weight, wrist strengthening ring, pilates stretch, stretch loop) will be prepared and then referred to the dialysis department of Baqiyatollah Hospital and according to the sample size (number of 45 people) by sampling in Subjects will be selected. Before starting the intervention, basic information will be collected from the subjects using demographic questionnaires. An informed satisfaction questionnaire will be taken from the study subjects. Adequacy of dialysis will be evaluated using blood biochemical tests (URR, KT/V, P, Ca, Na, K, PTH, HCo3-, and Plt) before the intervention. The sleep quality of the patients will be evaluated using Richard Campbell's sleep quality questionnaire. The quality of life of patients will be evaluated using the questionnaire of the quality of life of kidney patients. The demographic questionnaire has questions about age, sex, marital status, duration of hemodialysis in months, education, occupation, effect of treatment on employment status, type of vascular access, cause of kidney failure and presence of stress in the past six months, and questions about willingness to exercise regularly. Was. Questionnaire and evaluations will be taken before and after the test. First, the exercises are selected according to the patient's physical, physical condition, and ability, with the diagnosis of the sports physiologist, which exercises during dialysis: plastic ring: 3 sets of pressing the ring until disability and dumbbell: dumbbell forearm 3 sets of disability, dumbbell side push 3 sets of disability, Front dumbbell 3 sets of disability and stretch loop: leg abduction 3 sets of disability, front thigh 3 sets of disability and Pilates stretch, back of arm stretch 3 sets of disability, money maker 3 sets of disability that 1 set is added to the exercises every 2 weeks, up to a maximum of 5 sets at the end and rest There is at least 1 minute between the sets, and before starting the work sets, they warm up the muscles with 2 sets without weights and stretching. The duration of the intervention is 12 weeks, so that exercises will be performed 3 times per week during dialysis. Before starting to exercise, the patient will be discussed with him in relation to movement restrictions in order to choose the most suitable exercise for him in case of shortness of breath, increased heart rate, chest pain, irregular heartbeat, pain and muscle cramps, nausea, dizziness and Blurred vision to stop exercise. Exercises will start after half an hour from the start of dialysis and stability of the patient's vital signs. At the end of every month, in the final minutes of hemodialysis and before separating the patient from the machine, the pump will be adjusted to fifty milliliters per minute and a blood sample will be taken from the arterial set. Blood sampling will be done using an arterial needle before the injection of normal saline and heparin and in the last ten minutes of dialysis and will be sent to the hospital laboratory. After the last day of the intervention, on the final day, blood sampling will be done again to assess dialysis adequacy, Richard Campbell questionnaire to assess sleep quality and KDQOL-SFTM questionnaire to assess quality of life will be measured as a post-test.