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The effect of hip-knee strengthening exercises along with trunk muscle coordination exercises in water and land on psychological variables and postural control of patients with patellofemoral pain

Protocol summary

Study aim
Determining the effectiveness of exercises in both 4 and 8 weeks and comparing the effectiveness of exercises in 4 weeks with exercises in 8 weeks in the water and dry environment on reducing pain, fear of movement, pain catastrophizing, on reducing fluctuations Posture, disability and proprioception in patellofemoral pain
Design
A semi-experimental, double-blind study on women 25-45 years old, 80 patients according to G*Power software, Random Number Generator software was used for randomization.
Settings and conduct
The evaluations will be done in the rehabilitation laboratory of Dr. Ali Yelfani and the exercises will be done in the swimming pool and gym in Boali Sina University, Hamedan. The exercises are 24 sessions, 12 sessions in water and 12 sessions on land. One group will receive it in 4 weeks and the other group will receive it in 8 weeks. Assessors will be unaware of exercises and interventions.
Participants/Inclusion and exclusion criteria
The entry conditions are minimum pain intensity of 3 out of 10 on the visual analog scale, the presence of pain in the anterior region of the knee and around the patella during activities for more than 6 weeks and a positive Clark test. The conditions of non-entry are any type of injury in the knee joint, ligament and meniscus injury, history of surgery, effusion of the knee joint, any pathological condition and history of participating in physical therapy sessions in the last 2 months.
Intervention groups
Both groups will receive a combination of thigh-knee strengthening exercises with trunk muscle coordination exercises along with training in water and land. One group will receive 24 training sessions for 4 weeks and the other group for 8 weeks.
Main outcome variables
The variables are pain, disability, fear of movement and catastrophizing, motor performance, postural control, foot pressure distribution.

General information

Reason for update
Acronym
PFPF
IRCT registration information
IRCT registration number: IRCT20240406061423N1
Registration date: 2024-04-14, 1403/01/26
Registration timing: prospective

Last update: 2024-04-14, 1403/01/26
Update count: 0
Registration date
2024-04-14, 1403/01/26
Registrant information
Name
Elaheh Serkani
Name of organization / entity
Buali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 81 3833 1766
Email address
e.serkani@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-16, 1403/01/28
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hip-knee strengthening exercises along with trunk muscle coordination exercises in water and land on psychological variables and postural control of patients with patellofemoral pain
Public title
The effect of sports exercises in water and land on patellar femoral pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The person has a minimum pain intensity of 3 out of 10 on the visual analog scale A person has pain in the anterior region of the knee and around the patella in at least two of the following cases: walking, running, jumping, bicycling, squatting, kneeling, going up and down stairs, and sitting with bent knees for more than 6 weeks The result of Clark's test is positive Women should be in the age group of 25 to 45 years.
Exclusion criteria:
The person has ligament and meniscus injuries The person has arthritis of the knee joint The person has osteoarthritis The person has a history of surgery The person has a bruised knee The person has patellar instability The person has effusion of the knee joint People with any pathological conditions such as: neuro-muscular-skeletal disease in the lower limbs, heart failure, infectious skin diseases, open wounds, epilepsy, abnormal blood pressure The person has a history of participating in physiotherapy sessions in the last 2 months
Age
From 25 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the patients will be randomized using Random Number Generator software, and then they will be assigned to 2 groups based on the allocation concealment using the SNOSE method. One group will receive 24 training sessions for 4 weeks and the other group will receive 8 weeks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, there are two exercise groups, and the evaluators will be unaware of the conditions of the interventions and exercises of each group.
Placebo
Not used
Assignment
Parallel
Other design features
Using exercises in water and on land

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Boali Sina Hamadan University
Street address
Unit 3, Father Bldg, Shobeiri Alley, Saidieh St
City
Hamedan
Province
Hamadan
Postal code
6516775846
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.BASU.REC.1402.097

Health conditions studied

1

Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders

Primary outcomes

1

Description
Intensity of pain
Timepoint
At the beginning of the study and end of the exercises
Method of measurement
pain level with visual analog scale, on disability with Kujala questionnaire, on fear of movement with Tampa questionnaire, on catastrophizing and movement performance with 13-item catastrophizing questionnaire, measuring proprioceptiveness with goniometer as well as measuring postural control and plantar pressure distribution A foot presser will be used in the single-leg squat activity.

2

Description
Degree of disability
Timepoint
At the beginning of the study and end of the exercises
Method of measurement
Using the Kujala questionnaire

3

Description
Fear of movement
Timepoint
At the beginning of the study and end of the exercises
Method of measurement
Using the Tampa questionnaire

4

Description
Catastrophizing of pain and motor function
Timepoint
At the beginning of the study and end of the exercises
Method of measurement
13-item pain catastrophizing scale questionnaire

Secondary outcomes

1

Description
Postural control
Timepoint
The beginning of study and the end of exercises
Method of measurement
Performing a single leg squat test on a foot presser machine

Intervention groups

1

Description
Intervention group: This group will receive the combination of thigh-knee strengthening exercises with trunk muscle coordination exercises along with training in water and land in 24 sessions, 12 sessions in water and 12 sessions on land in a period of 4 weeks.
Category
Treatment - Other

2

Description
Intervention group: This group will receive the combination of thigh-knee strengthening exercises with trunk muscle coordination exercises along with training in water and land in 24 sessions, 12 sessions in water and 12 sessions on land in a period of 8 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Be'sat Hospital
Full name of responsible person
Ali Yalfani
Street address
Be'sat Hospital, Pajohesh Intersection
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Phone
+98 81 3140 0000
Email
yalfani@basu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Boali Sina, Hamedan
Full name of responsible person
Gholamhosein Majzobi
Street address
Boali Sina University, Ahmadi Roshan Boulevard
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Phone
+98 81 3140 0000
Email
info@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Boali Sina, Hamedan
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
The University of of Buali Sina
Full name of responsible person
Elaheh Serkani
Position
Postgraduate student
Latest degree
Bachelor
Other areas of specialty/work
Sports rehabilitation
Street address
Unit 3, Pedar Bldg, Farid Dead End, Shabeiri Alley, Saidieh St
City
Hamedan
Province
Hamadan
Postal code
6516775846
Phone
+98 81 3833 0762
Email
e.serkani@phe.basu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Buali Sina
Full name of responsible person
Elaheh Serkani
Position
Postgraduate student
Latest degree
Bachelor
Other areas of specialty/work
Sports rehabilitation
Street address
Unit 3, Pedar Bldg, Shabeiri Alley, Saidieh St
City
Hamedan
Province
Hamadan
Postal code
6516775846
Phone
+98 81 3833 0762
Email
e.serkani@phe.basu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Buali Sina
Full name of responsible person
Elaheh Serkani
Position
Postgraduate student
Latest degree
Bachelor
Other areas of specialty/work
Sports rehabilitation
Street address
Unit 3, Pedar Bldg, Shabeiri Alley, Saidieh St
City
Hamedan
Province
Hamadan
Postal code
6516775846
Phone
+98 81 3833 0762
Email
e.serkani@phe.basu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Data and documents can be shared, but with the non-identification of people and the preservation of private information of subjects.
When the data will become available and for how long
Access to data begins one year after results are published
To whom data/document is available
Researchers who conduct research in this direction are allowed to take action to receive documents.
Under which criteria data/document could be used
Only the type of analysis done in the research can be repeated.
From where data/document is obtainable
E-mail
What processes are involved for a request to access data/document
When the applicant provides documents for his field of work related to the topic of interest of the thesis, and in case of a reasonable request and a commitment not to misuse the data of this research, the data will be sent to him within one working week.
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