Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637124
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Different Levels of Blood Flow Restriction Versus Moderate Intensity Exercises in Patients with Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Blood Flow Restriction with Different Loads Versus Moderate Resistive Exercises in Patients with Knee Osteoarthritis a Double Blinded Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trail will be conducted to investigate the effect of blood flow restriction BFR with different load levels between low blood occlusion percentage 50 group and high blood occlusion percentage 70 compared to moderate intensity training 60 of 1 RM in patients with chronic knee osteoarthritis
The main questions it aims to answer are
1 Will there be no difference between the effect of 70 vs 50 of BFR versus traditional moderate resistive training exercises on pain intensity in knee osteoarthritis
2 Will there be no difference between the effect of 70 vs 50 of BFR versus traditional moderate resistive training exercises on quadriceps muscle strength in knee osteoarthritis
3 Will there be no difference difference between the effect of 70 vs 50 of BFR versus traditional moderate resistive training exercises on rate of perceived exertion in knee osteoarthritis
4 Will there be no difference between the effect of 70 vs 50 of BFR versus traditional moderate resistive training exercises on functional ability in knee osteoarthritis
5 Will there be no difference between the effect of 70 vs 50 of BFR versus traditional moderate resistive training exercises on physical function in knee osteoarthritis
All participants will receive
1 16 sessions of supervised intervention 2 times per week for 8 weeks
2 The assessment will be at 3 time points baseline and at 4 weeks and at 8 weeks
The main questions it aims to answer are
1 Will there be no difference between the effect of 70 vs 50 of BFR versus traditional moderate resistive training exercises on pain intensity in knee osteoarthritis
2 Will there be no difference between the effect of 70 vs 50 of BFR versus traditional moderate resistive training exercises on quadriceps muscle strength in knee osteoarthritis
3 Will there be no difference difference between the effect of 70 vs 50 of BFR versus traditional moderate resistive training exercises on rate of perceived exertion in knee osteoarthritis
4 Will there be no difference between the effect of 70 vs 50 of BFR versus traditional moderate resistive training exercises on functional ability in knee osteoarthritis
5 Will there be no difference between the effect of 70 vs 50 of BFR versus traditional moderate resistive training exercises on physical function in knee osteoarthritis
All participants will receive
1 16 sessions of supervised intervention 2 times per week for 8 weeks
2 The assessment will be at 3 time points baseline and at 4 weeks and at 8 weeks
Detailed Description:
Knee osteoarthritis KOA is a prevalent degenerative musculoskeletal condition that primarily causing pain stiffness and disability It is a multifactorial disease influenced by a combination of genetic biomechanical and environmental factors Osteoarthritis Research Society International ORSI recommended strength training as a possible treatment method to slow progression of knee OA Strength training as recommended by the American College of Sports Medicine ACSM must be performed at a minimum resistance training load of 60 to 70 1-repetition maximum 1RM for strength improvement
Only 13 of older patients with knee OA satisfactorily can perform moderate to vigorous physical activity
Unfortunately risk factors of knee OA as obesity knee pain knee injurysurgery also contribute to a perceived reduced tolerance to the resistive training programs recommended for eliciting strength gains
An alternative to traditional strength training that may be well tolerated by patients with Knee OA is Blood flow restriction BFR training
This reduced blood flow creates a unique physiological environment inducing a state of metabolic stress and cellular hypoxia in the muscles
Although the advantages of BFRT in musculoskeletal rehabilitation that reported in the literature there are conflicting results compared to traditional exercises as the different protocols parameters exercises high risk of bias across previous studies contribute to different conclusions
Consequently it raises the question if BFR without exercises can be effective in comparison with traditional exercises that focus on having an efficient intensity to produce muscle strength gain
Yet up to authors knowledge no study has assessed whether BFR at rest could also promote similar gains in muscle strength for the knee OA treatment which theoretically would increase patients adherence to KOA treatment based on conclusions of systemic review of BFR without exercises for immobilized patients after orthopedic surgery Cerqueira et al 2019
Another relevant issue is the proper blood flow restriction level for optimal results Thus pushes the need for determining a pressure load with the least adverse effects
Therefore the main purpose of this study is to assess different protocols of BFR without additional exercises compared to MI-RT for pain reduction in patients with KOA The secondary purpose is to compare two load levels 70 vs 50 of BFRT regarding pain quadriceps muscle strength rate of perceived exertion self reported physical function and functional ability
Only 13 of older patients with knee OA satisfactorily can perform moderate to vigorous physical activity
Unfortunately risk factors of knee OA as obesity knee pain knee injurysurgery also contribute to a perceived reduced tolerance to the resistive training programs recommended for eliciting strength gains
An alternative to traditional strength training that may be well tolerated by patients with Knee OA is Blood flow restriction BFR training
This reduced blood flow creates a unique physiological environment inducing a state of metabolic stress and cellular hypoxia in the muscles
Although the advantages of BFRT in musculoskeletal rehabilitation that reported in the literature there are conflicting results compared to traditional exercises as the different protocols parameters exercises high risk of bias across previous studies contribute to different conclusions
Consequently it raises the question if BFR without exercises can be effective in comparison with traditional exercises that focus on having an efficient intensity to produce muscle strength gain
Yet up to authors knowledge no study has assessed whether BFR at rest could also promote similar gains in muscle strength for the knee OA treatment which theoretically would increase patients adherence to KOA treatment based on conclusions of systemic review of BFR without exercises for immobilized patients after orthopedic surgery Cerqueira et al 2019
Another relevant issue is the proper blood flow restriction level for optimal results Thus pushes the need for determining a pressure load with the least adverse effects
Therefore the main purpose of this study is to assess different protocols of BFR without additional exercises compared to MI-RT for pain reduction in patients with KOA The secondary purpose is to compare two load levels 70 vs 50 of BFRT regarding pain quadriceps muscle strength rate of perceived exertion self reported physical function and functional ability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None