Determining the effect of balance exercises on cognitive function and activity daily living in elderly patients with heart failure
Design
Two arm parallel group clinical trial, double blinded and block randomization
Settings and conduct
The intervention will have the effect of balance exercises for eight weeks (60 days). And the blindness will be blind in two ways. The place of study is in Khorramabad and it is in the specialized clinics of Shahid Rahimi Hospital and Shahid Madani Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria including:
1) Male and female patients 60 to 75 years old and residents of Khorramabad
2) Patients with heart failure Class II and III
3) Independent mobility
4) Balance impairment (full tandem standing test < 10 seconds)
5) Having Cognitive dysfunction ( based on the MMSE test)
6) Get a score less than 14 based on (IADL) scale
7) No visual or auditory impairment
8) Able to understand and complete questionnaires in Persian
9) Willingness to participate in a 2-month balance training program
Exclusion criteria including:
1) Threatening cardiovascular events such as dangerous arrhythmias
2) Unstable hemodynamic status
3) Acute cerebral vascular stroke
4) Participate in other sports and rehabilitation programs such as yoga
Intervention groups
Balance exercises for 60 days are taught to 44 patients in the intervention group. Each balance exercise is repeated and lasts about 3-5 minutes, and the total duration of each daily training session is 30 minutes and four. Times will be weekly for eight weeks. One session per week is supervised by a nurse. Control group,receive only routine care.
Main outcome variables
Cognitive function score based on the Montreal test and activity daily living based on Bartel and Lawton scales
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150919024080N18
Registration date:2020-10-12, 1399/07/21
Registration timing:registered_while_recruiting
Last update:2020-10-12, 1399/07/21
Update count:0
Registration date
2020-10-12, 1399/07/21
Registrant information
Name
Mohammad Gholami
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 509 1279
Email address
gholami.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Balance Training on Cognitive Function and Activity of Daily Living of Elderly People with Heart Failure
Public title
The effect of balance training on the cognition and daily living of the elderly with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Class 2 and 3 heart failure based on the diagnosis of the treating physician and the functional class criteria of the New York Heart Association
Ability to walk independently and without the use of moving aids (canes and walkers) indoors and outdoors
balance impairment (based on the complete tandem standing test in less than 10 seconds)
Cognitive dysfunction score below 26 (based on the Montreal Cognitive Functional Disorder Questionnaire)
Having a dysfunction in daily activities Gaining a score of 14 from the Barthel questionnaire
Ability to make phone calls
Lack of restrictive exercises such as visual and auditory impairment
Having at least literacy and the ability to understand Persian
Exclusion criteria:
Diabetes mellitus and history of hypoglycemic and hyperglycemic attacks
Diabetic nephropathy and retinopathy, hypertensive crises
History of acute stroke
Dementia
Peripheral arterial disease
End-stage heart failure requires advanced treatment
Acute arthropathy or musculoskeletal disorders
Participate in other sports programs
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
After basic evaluations such as cardiovascular function evaluation tests by a cardiologist, patients are admitted to the study according to the inclusion and exclusion criteria, then by block randomization (Block Randomization) in two groups of treatment and control in a balanced way. Randomization is done using a random number table. In this sampling method, the classes will be based on the New York Heart Association functional class variables and literacy level. Patients will also be matched for age and gender. The sample size is calculated based on the change in the average daily activity or cognitive function of 88 patients with heart failure, of which 44 patients will be in the intervention group and 44 patients in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Studying on both sides will be blind. Patients are unaware that they are in the control or intervention group and are unaware of the research hypothesis. Data collection is done with the help of a researcher who is unaware of the random allocation of groups. Data analysis is also performed by a researcher who is unaware of the random allocation of groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, Lorestan, Khorram Abad, 5 Km.
City
Khorramabad
Province
Lorestan
Postal code
381351698
Approval date
2020-06-07, 1399/03/18
Ethics committee reference number
IR.LUMS.REC.1399.070
Health conditions studied
1
Description of health condition studied
Elderly patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cognitive performance score
Timepoint
Before the intervention, and one week after the 60-day treatment period
Method of measurement
Montreal cognitive assessment- Basic (MOCA_Bp) test
2
Description
Activity of Daily Living
Timepoint
Before the intervention, and one week after the 60-day treatment period
Method of measurement
Bartel & Lawton Activities of Daily Living scales
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: There are 44 patients in this group. Balance exercises in this group will be for 30 minutes every day and four times a week for eight weeks. Each balance exercise is repeated and lasts about 3-5 minutes. One session per week. Supervised by a nurse. The first supervision of the nurse will be during the first session and the next supervisions will be performed once a week with the coordination of the patient.
Category
Rehabilitation
2
Description
Control group: There are 44 patients in this group. In this group, no special sports intervention is performed and they receive only the usual care, including period visits by the treating physician.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Faezeh Zahrabi Salari
Street address
Shahid Ayatollah Madani Hospital,Shahid Beheshti St. (Khairabad), Imam Hossein Square,Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3341 9123
Email
fz.s711@ymail.com
2
Recruitment center
Name of recruitment center
Specialty Clinic of Shahid Madani Hospital
Full name of responsible person
Faezeh Zahrabi Salari
Street address
Mojahedin Street- Freedom Square - Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6814713115
Phone
+98 66 1223 6141
Email
fz.s711@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ebrahim Falahi
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
381251698
Phone
+98 66 3312 0172
Email
research@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Faezeh Zahrabi Salari
Position
Undergraduate Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medica
City
Khorram Abad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0139
Email
fz.s711@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mohammad Gholami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical
City
Khorram Abad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0139
Email
mohammad13565@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Faezeh Zahrabi Salari
Position
Undergraduate Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical
City
Khorram Abad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0139
Email
fz.s711@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available