Protocol summary

Study aim
Determining the effect of exercise program on sleep quality and quality of life in patients with osteoarthritis of the knee
Design
In this single-blind two arms parallel-group randomized trial, 70 patients are selected by convenience sampling and then randomly assigned to the intervention and control groups.
Settings and conduct
This clinical trial is performed in the orthopedic clinic of Allameh Bohlool Gonabadi Hospital. First, the quality of sleep and quality of life are measured. The intervention group will undergo exercise in the clinic for 4 weeks. 4 weeks later, exercise is done at home with the presence of the researcher. Then the quality of life and quality of sleep will be evaluated and compared in two groups. No intervention is performed for the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Over 60 years of age, ability to answer questions Physically and mentally, and participate in sports exercises based Exclusion criteria: Having health problems affecting exercise , osteoporosis
Intervention groups
First, the Pittsburgh Sleep Quality Index (PSQI) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) are completed by the intervention group and the control group. The intervention group will undergo a training program for 4 weeks (one 30-minute session per week). 4 weeks later, exercise is done at home with the presence of the researcher. Then the mentioned questionnaires will be evaluated and compared in two groups.
Main outcome variables
sleep quality; quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210129050172N1
Registration date: 2021-02-21, 1399/12/03
Registration timing: registered_while_recruiting

Last update: 2021-02-21, 1399/12/03
Update count: 0
Registration date
2021-02-21, 1399/12/03
Registrant information
Name
Sara Safarnia Shahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 6841
Email address
safarniasara@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-30, 1399/11/11
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Exercise Program on Improving Quality of Life and Sleep Quality in the Elderly with Osteoarthritis of the Knee
Public title
Investigating the effect of exercise program on improving sleep quality and quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have the criteria of the American College of Rheumatology in terms of clinical and radiographic Experiencing knee pain most days of the last month Ability to walk independently and perform daily activities independently Ability to answer the questionnaire's questions physically and mentally Physical and mental ability to participate in sports exercises based on the diagnosis of the treating physician Stability of blood pressure to participate in the study
Exclusion criteria:
Symptoms of knee lock Knee surgery and replacement in the last 6 months Severe knee deformity History of knee malignancy, wound and infection around the knee, history of knee fracture, knee hypermobility and instability Existence of metabolic and endocrine disorders such as diabetes, thyroid disease Having health problems affecting home exercise such as uncontrolled high blood pressure, heart disorder, brain disorder, shortness of breath, arrhythmia, severe vision problems. Chronic use of a knee brace, cane, walker or wheelchair Corticosteroid injection during the last 30 days Injection of hyaluronic acid into the symptomatic joint within the last six months Osteoporosis
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are assigned to the study groups (intervention and control) by blocking randomization method with 4 blocks.Randomization tool: https://www.sealedenvelope.com/simple-randomiser/v1/lists
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
Ethics committee of Shahed University
Street address
Shahed university – Opposite Holy Shrine of Imam Khomeini- Khalij Fars Expressway – Tehran - Iran
City
Tehran
Province
Tehran
Postal code
33191​18651
Approval date
2021-01-25, 1399/11/06
Ethics committee reference number
IR.SHAHED.REC.1399.145

Health conditions studied

1

Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Quality of life in KOOS and SF12 questionnaires
Timepoint
before the intervention and two months after the exercise program
Method of measurement
Knee Injury and Osteoarthritis Outcome Score (KOOS); 12-Item Short Form Health Survey (SF-12)

2

Description
quality of sleep in Pittsburgh Sleep Quality Index (PSQI)
Timepoint
before the intervention and two months after the exercise program
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First, the Pittsburgh Sleep Quality Index (PSQI) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) are completed by the intervention group. The intervention group will undergo a training program for 4 weeks (one 30-minute session per week). 4 weeks later, exercise is done at home with the presence of the researcher. Then the mentioned questionnaires will be evaluated and compared in this group.Exercises will be presented in 4 sessions of 30 minutes. The first session includes 7 exercises to strengthen the quadriceps muscles (such as intermittent contraction and relaxation of this muscle, standing on one foot and bringing the heel of the other foot closer to the small serine muscle, mini-squat movement, bridge exercises, straight leg raising exercises and ...).The second session includes 3 leg muscle stretching exercises (such as gentle leg stretching, standing on the wall with one leg in the back and the other leg in the front stretching, etc.) and 2 hamstring muscle stretching exercises (hamstring muscle stretching and Improve the range of motion of the knee by lying down and bringing one foot closer to the chest with the hands or a strap).The third session includes 2 exercises to strengthen the large serine muscle to control the torso, leg stability and balance while standing and walking (including strengthening these muscles while lying on the abdomen and contracting the buttocks and then raising one leg, sitting on a chair and while The knee is bent, lifting it off the floor) and 3 exercises to strengthen the legs (such as strengthening the legs by
Category
Rehabilitation

2

Description
Control group: No intervention is performed for the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Allameh Bohlool Gonabadi Hospital
Full name of responsible person
Sara Safarnia Shahri
Street address
No. 8 , Naser Khosrow 17 Alley. Naser Khosrow Street
City
Gonabad
Province
Razavi Khorasan
Postal code
9691845435
Phone
+98 51 5722 6841
Email
safarniasara@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Persian Gulf Highway (Tehran - Qom), facing the shrine Motahar Imam Khomeini, Shahed University
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3565
Fax
+98 21 5121 3564
Email
info@shahed.ac.ir
Web page address
https://www.shahed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
sara safarnia shahri
Position
M.Sc Student In Geriatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran province in front of Imam Khomeini shrine, Persian Gulf freeway
City
Tehran
Province
Tehran
Postal code
33191​18651
Phone
098 21 51213565
Fax
+98 21 5121 3564
Email
publicrelation@shahed.ac.ir
Web page address
https://www.shahed.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohammad Reza Heidari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Persian Gulf Highway (Tehran - Qom), facing the holy shrine Imam Khomeini, Shahed University
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3565
Fax
+98 21 5121 3564
Email
mheidari@shahed.ac.ir
Web page address
https://www.shahed.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Sara Safarnia Shahri
Position
Master of Science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8, Naser Khosrow Alley 17, Naser Khosrow Street
City
Gonabad
Province
Razavi Khorasan
Postal code
33191​18651
Phone
+98 51 5722 6841
Fax
Email
safarniasara@gmail.com
Web page address
https://www.shahed.ac.ir/

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
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