Exercise Dosages and Exercise Adherence With Patients With Knee Osteoarthritis (Adherence)
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Dosage Home Exercise Training
Standard Dosage Home Exercise Training
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Exercise Adherence, Exercise Dosage, Home Exercises
Eligibility Criteria
Inclusion Criteria:
- Having a diagnosis of unilateral or bilateral knee osteoarthritis.
- Being between stage 1-3 according to Kellgren-Lawrence criteria.
- Having at least 3 months of pain duration and decreased functioning.
- Being a volunteer who can read and write
Exclusion Criteria:
- Physiotherapy or other conservative therapy during the previous 3 months or a history of major knee trauma.
- Having Inflammatory joint disease, hip symptoms more aggravating than the knee symptoms,
- Having comorbidities not allowing exercise such as cardiovascular, respiratory, systemic, or metabolic conditions limiting exercise tolerance.
- Participants with previously performed knee replacement surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Exercise Group
High Dosage Exercise Group
Arm Description
Exercise training is given to patients in the form of a home exercise program.
The high dosage exercise training group will implement the recommended exercise program 3 times more than the standard exercise group.
Outcomes
Primary Outcome Measures
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Points at 12 weeks
(WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Change from Exercise Adherence (with Self Reported Exercise Diary) at 12 Weeks Percentages at 12 Weeks
In the exercise diary, the participant will note the number of exercises done at home next to the image showing the exercise example day by day.The percentage adherence to the prescribed exercise regimen was calculated by dividing the number of exercises performed by the number of exercises prescribed and multiplying by 100.
Change from Knee Osteoarthritis Exercise Adherence Scale Points at 12 Weeks
It consists of four yes / no questions.'Yes' answer is rated with 1 point, 'No' answer gets 0 point. Lesser scores indicate good exercise adherence.
Secondary Outcome Measures
Change from Visual Analogue Scale(for Pain) Points at 12 Weeks
The pain Visual Analogue Scale(VAS) is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured pain orientated from the left (worst) to the right (best).
Change from Tampa Scale for Kinesiophobia Points at 12 Weeks
The term kinesiophobia refers to a fear of pain with movement - i.e., movements which a patient is hesitant to perform due to fear that the movement will elicit pain. Likert scoring with 4 points (1 = Strongly disagree, 4 = I totally agree) is used in the scale. Tampa Scale for Kinesiophobia consists of 17 questions. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement. A total score is calculated after inversion of the individual scores of items 4, 8, 12 and 16.
Change from Timed Up&Go Test Score at 12 Weeks
The timed up and walk test(TUG) is used to measure the time it takes for the patient to get up from the chair, walk a distance of 3m, turn and sit on the same chair. TUG is a simple test used to assess a person's mobility and requires both static and dynamic balance. One source suggests that scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention.
Change from Timed 10 Meter Walk Test Score at 12 Weeks
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. The participant walks without assistance for 10 metres, with the time measured for the intermediate 6 metres to allow for acceleration and deceleration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04357145
Brief Title
Exercise Dosages and Exercise Adherence With Patients With Knee Osteoarthritis
Acronym
Adherence
Official Title
The Effect of Different Exercise Dosages on Exercise Adherence, Pain and Functionality in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Although the effects of different exercise dosages for patients with osteoarthritis are compared in the literature, it is seen that studies on which exercise dosage is better are insufficient.The planned study has 2 main objectives:
To examine the effects of different exercise dosages on exercise dependence
To investigate the effect of different exercise dosages on pain and functional results
Detailed Description
Knee osteoarthritis (KO) is the most common musculoskeletal problem worldwide, leading to pain and loss of locomotor function. The Framingham Osteoarthritis Study shows that 19% of adults have radiographic effects on the knee joint. Individuals with advanced symptomatic KO have difficulties in their daily life activities. Among all diseases, KO most affects activities such as walking, climbing stairs and housework. A wide range of physiotherapy treatment methods are available in KO treatment such as strengthening exercises, aquatic exercises, aerobic exercises, proprioception exercise, orthotics, taping methods and the use of electrophysiological agents. High-quality evidences suggests that land-based exercise therapy maintains its positive effect on pain, quality of life and functionality for 2-6 months after the treatment. The dosage of exercise therapy can be adjusted by the duration, frequency, or resistance of the exercise. However, evidence-based information on exercise dosage is limited in KO treatment. While KO is treated in physiotherapy clinics, it is also supported by home exercises during and after treatment. However, it is a clinical problem that patients show low adherence to home exercise. With this study, it is aimed to compare the exercise adherence of patients who are given home exercise with different exercise dosages and to show their functional results. Participants with KO aged between 40-85 years will be included in the study and randomly divided into two groups. The number of repetitions of the high dosage exercise group will be 2 times more than standard exercise group. Participants will be asked to apply home exercise programs 4 times a week. Exercise adherence, pain, kinesiophobia and functionality will be evaluated. Our study will be the first to demonstrate the effect of different home exercise dosages on exercise adherence. The information to be obtained with this study is thought to contribute to the preparation of a better home exercise program. With the information to be obtained through this study, it can contribute to the preparation of a better home exercise program.The planned study has 2 main objectives:
To examine the effects of different exercise dosages on exercise dependence
To investigate the effect of different exercise dosages on pain and functional results
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, Exercise Adherence, Exercise Dosage, Home Exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Exercise Group
Arm Type
Active Comparator
Arm Description
Exercise training is given to patients in the form of a home exercise program.
Arm Title
High Dosage Exercise Group
Arm Type
Experimental
Arm Description
The high dosage exercise training group will implement the recommended exercise program 3 times more than the standard exercise group.
Intervention Type
Other
Intervention Name(s)
High Dosage Home Exercise Training
Intervention Description
By giving more exercise to the experimental group, exercise adherence, pain and functionality will be compared with the standard exercise group.
3 times more reputation than control
Exercise Program to be Applied (0-3 Weeks):
Isometric knee extensor and adductor exercise
Hamstring stretching exercise
Terminal knee extension exercise
Straight leg lifting exercise
Exercise Program to be Applied (3-12 Weeks):
Stepping exercise
Sit up and stand up without support
Active knee flexion exercise
Moving forward exercise
Intervention Type
Other
Intervention Name(s)
Standard Dosage Home Exercise Training
Intervention Description
5-6 standard reputations for all exercises
Exercise Program to be Applied (0-3 Weeks):
Isometric knee extensor and adductor exercise
Hamstring stretching exercise
Terminal knee extension exercise
Straight leg lifting exercise
Exercise Program to be Applied (3-12 Weeks):
Stepping exercise
Sit up and stand up without support
Active knee flexion exercise
Moving forward exercise
Primary Outcome Measure Information:
Title
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Points at 12 weeks
Description
(WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Baseline, Week 3, Week 6 and Week 12
Title
Change from Exercise Adherence (with Self Reported Exercise Diary) at 12 Weeks Percentages at 12 Weeks
Description
In the exercise diary, the participant will note the number of exercises done at home next to the image showing the exercise example day by day.The percentage adherence to the prescribed exercise regimen was calculated by dividing the number of exercises performed by the number of exercises prescribed and multiplying by 100.
Time Frame
Week 3, Week 6, Week 9, Week 12
Title
Change from Knee Osteoarthritis Exercise Adherence Scale Points at 12 Weeks
Description
It consists of four yes / no questions.'Yes' answer is rated with 1 point, 'No' answer gets 0 point. Lesser scores indicate good exercise adherence.
Time Frame
Week 3, Week 6, Week 9, Week 12
Secondary Outcome Measure Information:
Title
Change from Visual Analogue Scale(for Pain) Points at 12 Weeks
Description
The pain Visual Analogue Scale(VAS) is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured pain orientated from the left (worst) to the right (best).
Time Frame
Baseline, Week 3, Week 6 and Week 12
Title
Change from Tampa Scale for Kinesiophobia Points at 12 Weeks
Description
The term kinesiophobia refers to a fear of pain with movement - i.e., movements which a patient is hesitant to perform due to fear that the movement will elicit pain. Likert scoring with 4 points (1 = Strongly disagree, 4 = I totally agree) is used in the scale. Tampa Scale for Kinesiophobia consists of 17 questions. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement. A total score is calculated after inversion of the individual scores of items 4, 8, 12 and 16.
Time Frame
Baseline, Week 3, Week 6 and Week 12
Title
Change from Timed Up&Go Test Score at 12 Weeks
Description
The timed up and walk test(TUG) is used to measure the time it takes for the patient to get up from the chair, walk a distance of 3m, turn and sit on the same chair. TUG is a simple test used to assess a person's mobility and requires both static and dynamic balance. One source suggests that scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention.
Time Frame
Baseline, Week 3, Week 6 and Week 12
Title
Change from Timed 10 Meter Walk Test Score at 12 Weeks
Description
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. The participant walks without assistance for 10 metres, with the time measured for the intermediate 6 metres to allow for acceleration and deceleration.
Time Frame
Baseline, Week 3, Week 6 and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having a diagnosis of unilateral or bilateral knee osteoarthritis.
Being between stage 1-3 according to Kellgren-Lawrence criteria.
Having at least 3 months of pain duration and decreased functioning.
Being a volunteer who can read and write
Exclusion Criteria:
Physiotherapy or other conservative therapy during the previous 3 months or a history of major knee trauma.
Having Inflammatory joint disease, hip symptoms more aggravating than the knee symptoms,
Having comorbidities not allowing exercise such as cardiovascular, respiratory, systemic, or metabolic conditions limiting exercise tolerance.
Participants with previously performed knee replacement surgery
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercise Dosages and Exercise Adherence With Patients With Knee Osteoarthritis
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