Protocol summary

Study aim
This study aims to evaluate the effects of high-intensity versus low-intensity resistance training along with blood flow restriction on pain, range of motion, strength, muscle thickness, and functional performance in patients with total knee arthroplasty.
Design
parallel-group, single-blind, randomized clinical trial
Settings and conduct
Setting: Allied Hospital, Faisalabad single-blinded study. assessor will be blind.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA • Both male and female patients • 50 to 65 years of age • Post-total knee arthroplasty for osteoarthritis • Unilateral joint replacement surgery EXCLUSION CRITERIA • Impaired cognitive function and mental disease (e.g., diagnosis of Alzheimer's disease) • Paraplegia/extremity amputation • End-stage renal disease requiring dialysis • Uncontrolled cardiovascular disease or Severe pulmonary disease • Active neoplasm • Body mass index greater than 40 kg/m² • Peripheral vascular disease or deep vein thrombosis • Opioid use and Chronic oral steroid use and anticoagulation use • Ipsilateral joint disease involving hip, ankle, or spine • Neurologic or other etiology of quadriceps wasting
Intervention groups
Both groups will receive the same baseline treatment. Group A: BFR with Low-Intensity Resistance training 5 min light cycling • Start with 10 repetitions of unliteral leg press at light weights • Calf raises • Knee flexion • Knee extension Progress to 20-30% of predicted 1RM Group B: BFR with High-Intensity Resistance training 5 min light cycling • Start with 10 repetitions of unliteral leg press at light weights • Calf raises • Knee flexion • Knee extension Progress to 65-70% of predicted 1RM
Main outcome variables
NPRS → Pain Universal goniometer → ROM Hand-held dynamometer → Strength Muscle mass → Ultrasound imaging Functional Performance • Lower extremity function scale • 6-Minute walk test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190717044238N13
Registration date: 2024-05-12, 1403/02/23
Registration timing: registered_while_recruiting

Last update: 2024-05-12, 1403/02/23
Update count: 0
Registration date
2024-05-12, 1403/02/23
Registrant information
Name
Fareeha Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 99200600
Email address
fari_fairy22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-06, 1403/02/17
Expected recruitment end date
2024-07-30, 1403/05/09
Actual recruitment start date
2024-05-12, 1403/02/23
Actual recruitment end date
2024-08-02, 1403/05/12
Trial completion date
2024-08-10, 1403/05/20
Scientific title
Effects of High-Intensity Versus Low-Intensity Resistance Training Along With Blood Flow Restriction in Patients with Total Knee Arthroplasty
Public title
Effects of resistance training in patients after total knee replacement surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female patients 50 to 65 years of age (27) Post-total knee arthroplasty for osteoarthritis Unilateral joint replacement surgery
Exclusion criteria:
Impaired cognitive function and mental disease (e.g., diagnosis of Alzheimer's disease) Paraplegia/extremity amputation End-stage renal disease requiring dialysis Uncontrolled cardiovascular disease or Severe pulmonary disease Active neoplasm Body mass index greater than 40 kg/m² Peripheral vascular disease or deep vein thrombosis Opioid use and Chronic oral steroid use and anticoagulation use Ipsilateral joint disease involving hip, ankle, or spine Neurologic or other etiology of quadriceps wasting
Age
From 50 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 34
Actual sample size reached: 34
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be done by using computer generated randomizer. Allocation will be concealed by sealed envelope method.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be a single blinded study. Assessor will be kept blind about the group allocation and previous readings.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and ethics Commitee Riphah College of Rehabilitation and Allied Health Sciences
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Postal code
54000
Approval date
2024-04-03, 1403/01/15
Ethics committee reference number
REC/RCR & AHS/23/0189

Health conditions studied

1

Description of health condition studied
Total knee arthroplasty
ICD-10 code
Z96.65
ICD-10 code description
Presence of artificial knee joint

Primary outcomes

1

Description
Pain
Timepoint
baseline , at 4th week and post training at 8th week
Method of measurement
Numeric Pain Rating Scale (NPRS)

2

Description
knee range of motion ROM
Timepoint
baseline , at 4th week and post training at 8th week
Method of measurement
Universal Goniometer

3

Description
Strength
Timepoint
baseline , at 4th week and post training at 8th week
Method of measurement
Hand-Held Dynamometer

4

Description
Quadriceps muscle thickness
Timepoint
baseline & at the end of 8th week
Method of measurement
Ultrasound Imaging

5

Description
Functional Performance
Timepoint
baseline , at 4th week and post training at 8th week
Method of measurement
a) Lower Extremity Function Scale b) 6-Minute Walk Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:1BFR with Low Intensity Resistance training ( For the first two weeks participants will follow home plan of standard physical therapy. Resistance training will be started if patient weight bears on unilateral leg for 5 s without support, have knee ROM of 0-90° able to perform repeated straight leg raise without knee extensor muscle lag. Patients 10 Repetition maximum (RM) will be used to predict 1 RM value according to formula 10 RM/ 0.75. BFR will be achieved using a tourniquet, and limb occlusion pressure (LOP) will be calculated, defined as the minimum pressure required for full arterial occlusion. Its will be calculated as baseline Systolic blood pressure (SBP) and formula for safety margins will be applied: add 40-50 mm Hg for SBP<130, Add 60-75 mm Hg for SBP 131-190, Add 80 mm Hg for SBP > 190. 60% of the calculated pressure will be used. Prior to exercise the cuff will be placed on the most proximal portion of the limb. -Standard Physical Therapy:1) Ankle Pumps2) AAROM/ AROM3) Quadriceps, Hamstrings and adductor setting Exercises 4) Patellar Mobilization (grade I, II) 5) Hamstrings, Calf & IT Band Stretching -Resistance Training:5 min light cycling• Start with 10 repetitions of unliteral leg press at light weights• Calf raises • Knee flexion• Knee extension. Progress to 20-30% of predicted 1RM
Category
Rehabilitation

2

Description
Intervention group: 2 BFR with High Intensity Resistance training (Resistance training will be started if patient weight bears on unilateral leg for 5 s without support, have knee ROM of 0-90° able to perform repeated straight leg raise without knee extensor muscle lag. Patients 10 Repetition maximum (RM) will be used to predict 1 RM value according to formula 10 RM/ 0.75. BFR will be achieved using a tourniquet, and limb occlusion pressure (LOP) will be calculated, defined as the minimum pressure required for full arterial occlusion. Its will be calculated as baseline Systolic blood pressure (SBP) and formula for safety margins will be applied: add 40-50 mm Hg for SBP<130, Add 60-75 mm Hg for SBP 131-190, Add 80 mm Hg for SBP > 190. 60% of the calculated pressure will be used. Prior to exercise the cuff will be placed on the most proximal portion of the limb. -Standard Physical Therapy:1) Ankle Pumps2) AAROM/ AROM3) Quadriceps, Hamstrings and adductor setting Exercises4) Patellar Mobilization (grade I, II)5) Hamstrings, Calf & IT Band Stretching -Resistance Training:5 min light cycling• Start with 10 repetitions of unliteral leg press at light weights• Calf raises • Knee flexion• Knee extension. Progress to 65-70% of predicted 1RM
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Allied Hospital, Faisalabad
Full name of responsible person
Maira Shahzad
Street address
Dr. Tusi road
City
Faisalabad
Postal code
38000
Phone
+92 41 9210095
Email
help@ahfsd.pk
Web page address
https://ahfsd.pk/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Fareeha Amjad
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University Lahore
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Maira Shahzad
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 312 6635635
Email
maairashahzad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Fareeha Amjad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Maira Shahzad
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 312 6635635
Email
maairashahzad@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
confidentiality of participants
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
Consent form in its original format with no information about any participant study protocol -how the intervention was given to both groups
When the data will become available and for how long
Data would be available after the completion of the research
To whom data/document is available
People working in an academic and clinical setting can have access to the above mentioned information/documents
Under which criteria data/document could be used
Data can be used for research paper
From where data/document is obtainable
Data can be asked at following email maairashahzad@gmail.com
What processes are involved for a request to access data/document
One can ask for data at the given email address and it would be provided after knowing the general implications of sharing that particular data
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