The Effect of Exercise Combination on Pain, Function and Proprioception in Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Stretching and Aerobic Exercise at Clinic
Strenghthening and Aerobic Exercise
Strengthening, Stretching and Aerobic Exercises at clinic
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring ostearthritis, stretching, strengthening, aerobic exercises
Eligibility Criteria
Inclusion Criteria:
- Being diagnosed as knee osteoarthritis
- Being between the ages 45-74
- Being at stage 2-3 according to Kellegren Lawrence Classification
- Having body mass index lower than 30
- Being volunteer for participation to this study
Exclusion Criteria:
- Refusing to participation to study
- Having another orthopeadic problem ralated to lower extremity
- Having uncontrollable hypertension
- Having arterial and venous disease
- Having neurological disease
- Having perceptual problem
- Having cardiac pacemaker
- Participation to physiotherapy program in the last 6 months for the same extremity
- Taking injection from the same extremity in the last 6 months
Sites / Locations
- Seda Baktır
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Combination of Stretching and Aerobic Exercises at Clinic
Combination of Strengthening and Aerobic Exercises at Clinic
Combination of Strengthening, Stretching and Aerobic Exercises at Clinic
Arm Description
Combination of Stretching and Aerobic Exercises at Clinic and Strengthening and Aerobic Exercises at Home
Combination of Strengthening and Aerobic Exercises at Clinic and Stretching and Aerobic Exercises at Home
Combination of Strengthening, Stretching and Aerobic Exercises at Clinic and Aerobic Exercises at Home
Outcomes
Primary Outcome Measures
The Western Ontario and McMaster Universities Arthritis Index
The Western Ontario and McMaster Universities Arthritis Index is a questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright
Stiffness (2 items): after first waking and later in the day
Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
The increasing scores reflect improvement of the function.
Numeric Pain Rating Scale
The Numeric Pain Rating Scale is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 likert type integers) that best reflects the intensity of his/her pain.The levels of pain felt at rest / activity / night will be evaluated. The increase in pain scores demonstrate that the health status get worse.
Pain Pressure Treshold (PPT)
Pain Pressure Treshold is evaluated via algometric measurement that were taken from 4 point including the mid portion of patella, 3 cm medial to patellar midline, 3 cm lateral to patellar midline, 2 cm above to patellar upper boundary.The increase in algometric measurement demonstrate the development in the pain sensitivity.
Range of Motion at knee joint both in flexion and extension
Range of motion is evaluated by using electronic goniometer for knee flexion and knee extension angles at the beginning and end of treatment. Increase in Range of Motion values of knee joint reflects the improvement of knee joint mobility.
Muscle strength for knee flexor and extensor muscles
Knee joint muscle strength was measured by using hand-held dinamometer. The measurements had taken for quadrieps and hamstring muscles. the incresing muscle strength values reflects improvement of strength of muscles around knee joint.
Secondary Outcome Measures
Proprioception
Proprioception will be evaluated with digital inclinometer from 90 degree knee flexion to 30 degree knee flexion angle. The deviation from this interval reflects that the detoriation of knee joint proprioception. Therefore, decreasing deviation scores obtained from the inclinometer reflects better proprioceptive sensation.
Aerobic Capacity
"6 Minute Walk Test'' is used for evaluation of Aerobic Capacity. The object of this test is to walk as far as possible for 6 minutes. Participants will walk back and forth in this hallway. Six minutes is a long time to walk, so participants will be exerting herself/himself. Participants will probably get out of breath or become exhausted. Necessary time should be permitted to herself/himself to slow down, to stop, and to rest. Participants may lean against the wall while resting, but resume walking as soon as possible. The increase in distance that it is walked in 6 minutes means that the aerobic capacity was developed.
Full Information
NCT ID
NCT05054686
First Posted
September 12, 2021
Last Updated
August 1, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05054686
Brief Title
The Effect of Exercise Combination on Pain, Function and Proprioception in Knee Osteoarthritis
Official Title
The Effect of Exercise Combination in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will include 3 different groups of intervention. First group of knee osteoarthritis patients will be applied both strengthening and 30 minutes bicycle exercises in the same session, 2 days strecthing exercises and 30 minutes walking will be given in seperate days as home program, Second group of knee osteoarthritis patients will be applied both stretching and 30 minutes bicycle exercises in the same session, strengthening exercises and 30 minutes walking will be given in seperate days as home program.Third group of knee osteoarthritis patients will be applied all stretching, strengthening and 30 minutes bicycle exercises in the same session, only 30 minutes walking will be given as home program. The primary outcome measures include the pain, function and the secondary outcome measures include the joint proprioception. The aim of this study is to investigate the effects on outcome measures increasing number of exercises in one session and to determine which exercise types are more suitable to prescribe as a home program.
Detailed Description
This study will include 3 different groups of intervention. First group of knee osteoarthritis patients will be applied both strengthening and bicycle exercises in the same session and strecthing exercises and walking will be given as home program in the days other than treatment session. Second group of knee osteoarthritis patients will be applied both stretching and bicycle exercises in the same session and strengthening exercises and walking will be given as home program in the days other than treatment session. Third group of knee osteoarthritis patients will be applied all stretching, strengthening and bicycle exercises in the same session and only walking exercise will be given as home program in the days other than treatment session. The primary outcome measures include the pain, function and the secondary outcome measures include the joint proprioception and aerobic capacity. The aim of this study is to investigate the effects increasing number of exercises in one session on outcome measures consisting of pain, function and proprioception. The pain will be evaluated both subjectively with numeric pain scale and WOMAC scale and objectively with pressure algometer. The function will be subjectively evaluated with WOMAC scale and objectively by measuring the knee joint range of motion and muscle strength for both flexor and extensor muscles. The evaluation of joint proprioception will be evaluated with inclinometer. The aerobic capacity will be objectively evaluated with 6 minute walk test. All the groups will be treated 2 days per week. The duration of total treatment lasts 8 weeks. All the groups practice aerobic exercises 2 days with bicycle ergometer application in the clinic, and 2 days walking outside as home program. Strecthing exercises will be applied for knee flexor and knee extensor muscles. Isometric strengthening exercises will be applied for knee extensor muscles. Isotonic strengthening exercises will be applied for hip abductor muscles, hip extensor muscles, hip flexor muscles, knee flexor muscles and knee extensor muscles. The treatment outcomes will be evaluated both at the beginning of treatment and at the end of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
ostearthritis, stretching, strengthening, aerobic exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Parallel Group Comparison Study
Masking
ParticipantInvestigator
Masking Description
Double Blind
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination of Stretching and Aerobic Exercises at Clinic
Arm Type
Experimental
Arm Description
Combination of Stretching and Aerobic Exercises at Clinic and Strengthening and Aerobic Exercises at Home
Arm Title
Combination of Strengthening and Aerobic Exercises at Clinic
Arm Type
Active Comparator
Arm Description
Combination of Strengthening and Aerobic Exercises at Clinic and Stretching and Aerobic Exercises at Home
Arm Title
Combination of Strengthening, Stretching and Aerobic Exercises at Clinic
Arm Type
Active Comparator
Arm Description
Combination of Strengthening, Stretching and Aerobic Exercises at Clinic and Aerobic Exercises at Home
Intervention Type
Other
Intervention Name(s)
Stretching and Aerobic Exercise at Clinic
Intervention Description
In this group of knee osteoarthritis patients will be applied both stretching and 30 minutes bicycle exercises in the same session, strengthening exercises and 30 minutes walking will be given in seperate days as home program.
Intervention Type
Other
Intervention Name(s)
Strenghthening and Aerobic Exercise
Intervention Description
In this group of knee osteoarthritis patients will be applied both strengthening and 30 minutes bicycle exercises in the same session, 2 days strecthing exercises and 30 minutes walking will be given in seperate days as home program.
Intervention Type
Other
Intervention Name(s)
Strengthening, Stretching and Aerobic Exercises at clinic
Intervention Description
In this group of knee osteoarthritis patients will be applied all stretching, strengthening and 30 minutes bicycle exercises in the same session, only 30 minutes walking will be given as home program.
Primary Outcome Measure Information:
Title
The Western Ontario and McMaster Universities Arthritis Index
Description
The Western Ontario and McMaster Universities Arthritis Index is a questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright
Stiffness (2 items): after first waking and later in the day
Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
The increasing scores reflect improvement of the function.
Time Frame
Change of The Western Ontario and McMaster Universities Arthritis Index scores from the beginning to the end of study (8 weeks)
Title
Numeric Pain Rating Scale
Description
The Numeric Pain Rating Scale is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 likert type integers) that best reflects the intensity of his/her pain.The levels of pain felt at rest / activity / night will be evaluated. The increase in pain scores demonstrate that the health status get worse.
Time Frame
Change of Numeric Pain Rating Scale scores from the beginning to the end of study (8 weeks)
Title
Pain Pressure Treshold (PPT)
Description
Pain Pressure Treshold is evaluated via algometric measurement that were taken from 4 point including the mid portion of patella, 3 cm medial to patellar midline, 3 cm lateral to patellar midline, 2 cm above to patellar upper boundary.The increase in algometric measurement demonstrate the development in the pain sensitivity.
Time Frame
Change of Pain Pressure Treshold measurements from the beginning to the end of study (8 weeks)
Title
Range of Motion at knee joint both in flexion and extension
Description
Range of motion is evaluated by using electronic goniometer for knee flexion and knee extension angles at the beginning and end of treatment. Increase in Range of Motion values of knee joint reflects the improvement of knee joint mobility.
Time Frame
Change of Range of Motion measurements from the beginning to the end of study (8 weeks)
Title
Muscle strength for knee flexor and extensor muscles
Description
Knee joint muscle strength was measured by using hand-held dinamometer. The measurements had taken for quadrieps and hamstring muscles. the incresing muscle strength values reflects improvement of strength of muscles around knee joint.
Time Frame
Change of muscle strength measurements from the beginning to the end of study (8 weeks)
Secondary Outcome Measure Information:
Title
Proprioception
Description
Proprioception will be evaluated with digital inclinometer from 90 degree knee flexion to 30 degree knee flexion angle. The deviation from this interval reflects that the detoriation of knee joint proprioception. Therefore, decreasing deviation scores obtained from the inclinometer reflects better proprioceptive sensation.
Time Frame
Change of Inclinometric measurements from the beginning to the end of study (8 weeks).
Title
Aerobic Capacity
Description
"6 Minute Walk Test'' is used for evaluation of Aerobic Capacity. The object of this test is to walk as far as possible for 6 minutes. Participants will walk back and forth in this hallway. Six minutes is a long time to walk, so participants will be exerting herself/himself. Participants will probably get out of breath or become exhausted. Necessary time should be permitted to herself/himself to slow down, to stop, and to rest. Participants may lean against the wall while resting, but resume walking as soon as possible. The increase in distance that it is walked in 6 minutes means that the aerobic capacity was developed.
Time Frame
Change of 6 Minute Walk Test from the beginning to the end of study (8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Being diagnosed as knee osteoarthritis
Being between the ages 45-74
Being at stage 2-3 according to Kellegren Lawrence Classification
Having body mass index lower than 30
Being volunteer for participation to this study
Exclusion Criteria:
Refusing to participation to study
Having another orthopeadic problem ralated to lower extremity
Having uncontrollable hypertension
Having arterial and venous disease
Having neurological disease
Having perceptual problem
Having cardiac pacemaker
Participation to physiotherapy program in the last 6 months for the same extremity
Taking injection from the same extremity in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seda BAKTIR, MSc.PT.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seda Baktır
City
Küçükçekmece
State/Province
Alkent 2000, Büyükçekmece/İstanbul
ZIP/Postal Code
34307
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We planned not to make group' data available to other researchers.
Learn more about this trial
The Effect of Exercise Combination on Pain, Function and Proprioception in Knee Osteoarthritis
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