Back to resultsA Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Blood flow restriction training + Anti-gravity treadmill
Anti-gravity treadmill
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria: Age included between 45 and 70 years old Patients with knee OA diagnosed by a medical doctor with a radiological confirmation Patients able to provide informed consent and follow all the study procedures as indicated by the protocol Informed Consent as documented by signature Exclusion Criteria: Younger than 44 years old or older than 71 years old included Known drug or alcohol abuse Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. Participation in another study with an investigational drug within the 30 days preceding and during the present study Treatment with an injective approach in the previous 3 month Surgical treatment in the previous 12 months.
Sites / Locations
- Christian CandrianRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anti-gravity treadmill + Blood Flow Restriction training
Anti-gravity treadmill
Arm Description
Outcomes
Primary Outcome Measures
Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index
Questionnaire at baseline (day 1) and 6 weeks, and at 3, 6 months. The WOMAC questionnaire is composed of 3 sub-scores that evaluate pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points), and function (17 questions, 0-68 points) and is a validated patient-reported outcome measure (PROM) to evaluate knee osteoarthritis.
Secondary Outcome Measures
Full Information
NCT ID
NCT05728827
First Posted
February 3, 2023
Last Updated
August 4, 2023
Sponsor
Ente Ospedaliero Cantonale, Bellinzona
1. Study Identification
Unique Protocol Identification Number
NCT05728827
Brief Title
A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis
Official Title
Rehabilitation With Blood Flow Restriction Training to Enhance Anti-gravity Treadmill Effects in the Treatment of Patients With Knee Osteoarthritis: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ente Ospedaliero Cantonale, Bellinzona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this randomized controlled study is to investigate whether the implementation of Blood Flow Restriction, in which the de-loading factor is delivered by the combined progressive de-loaded walking to running activity on an antigravity treadmill (treatment group), is more effective than the same antigravity protocol alone (control group).
Participants will be divided as follows:
Intervention group: anti-gravity treadmill combined with blood flow restriction Control group: anti-gravity treadmill Both groups will also undergo a standardized knee Osteoarthritis management through an aerobic and strength program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anti-gravity treadmill + Blood Flow Restriction training
Arm Type
Experimental
Arm Title
Anti-gravity treadmill
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Blood flow restriction training + Anti-gravity treadmill
Intervention Description
Blood flow restriction training is administered via straps applied to the proximal limb with the possibility to adjust the applied occlusion pressure in order to prevent venous return leaving the arterial flow partially free. The consequent blood pooling causes a reduction in tissue saturation with oxidative stress and an increased growth factors secretion. The intervention will be applied while walking/running on the anti-gravity treadmill.
Intervention Type
Other
Intervention Name(s)
Anti-gravity treadmill
Intervention Description
The intervention will be applied walking/running on the anti-gravity treadmill.
Primary Outcome Measure Information:
Title
Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index
Description
Questionnaire at baseline (day 1) and 6 weeks, and at 3, 6 months. The WOMAC questionnaire is composed of 3 sub-scores that evaluate pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points), and function (17 questions, 0-68 points) and is a validated patient-reported outcome measure (PROM) to evaluate knee osteoarthritis.
Time Frame
Change from Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age included between 45 and 70 years old
Patients with knee OA diagnosed by a medical doctor with a radiological confirmation
Patients able to provide informed consent and follow all the study procedures as indicated by the protocol
Informed Consent as documented by signature
Exclusion Criteria:
Younger than 44 years old or older than 71 years old included
Known drug or alcohol abuse
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Participation in another study with an investigational drug within the 30 days preceding and during the present study
Treatment with an injective approach in the previous 3 month
Surgical treatment in the previous 12 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastiano Nutarelli, MS
Phone
0041918117029
Email
s.nutarelli@mail.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Candrian, MD
Organizational Affiliation
EOC
Official's Role
Study Chair
Facility Information:
Facility Name
Christian Candrian
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Candrian, MD
Phone
+41 (0) 91 811 61 23
Email
christian.candrian@eoc.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis
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