Knee OsteoarthritisAdherenceNCT04357145
Exercise Dosages and Exercise Adherence With Patients With Knee Osteoarthritis
A study testing High Dosage Home Exercise Training and Standard Dosage Home Exercise Training in people with Knee Osteoarthritis, run by Marmara University.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- High Dosage Home Exercise Training and Standard Dosage Home Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Effect of Different Exercise Dosages on Exercise Adherence, Pain and Functionality in Patients With Knee Osteoarthritis
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
Read the 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
- Conditions
- Knee Osteoarthritis
- Being tested
- High Dosage Home Exercise Training, Standard Dosage Home Exercise Training
- Keywords
- Knee Osteoarthritis, Exercise Adherence, Exercise Dosage, Home Exercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dosage Home Exercise TrainingOther
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
Standard Dosage Home Exercise TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard Exercise Group | Active comparator | Exercise training is given to patients in the form of a home exercise program. Receives: Other: Standard Dosage Home Exercise Training |
| High Dosage Exercise Group | Experimental | The high dosage exercise training group will implement the recommended exercise program 3 times more than the standard exercise group. Receives: Other: High Dosage Home Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 3, Week 6 and Week 12
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.
Measured: Week 3, Week 6, Week 9, Week 12
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.
Measured: Week 3, Week 6, Week 9, Week 12
Secondary outcomes (4)
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).
Measured: Baseline, Week 3, Week 6 and Week 12
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.
Measured: Baseline, Week 3, Week 6 and Week 12
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.
Measured: Baseline, Week 3, Week 6 and Week 12
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.
Measured: Baseline, Week 3, Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Tonga, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357145
- Sponsor's protocol ID
- 563254
- Acronym
- Adherence
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Exercise Dosages on Exercise Adherence, Pain and Functionality in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04357145
- Acronym / sponsor ID
- Adherence / 563254
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Exercise Adherence, Exercise Dosage, Home Exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Exercise Group | Active comparator | Other: Standard Dosage Home Exercise TrainingExercise training is given to patients in the form of a home exercise program. |
| High Dosage Exercise Group | Experimental | Other: High Dosage Home Exercise TrainingThe high dosage exercise training group will implement the recommended exercise program 3 times more than the standard exercise group. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dosage Home Exercise TrainingBy 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 | Other | High Dosage Exercise Group |
| Standard Dosage Home Exercise Training5-6 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 | Other | Standard Exercise Group |
Primary outcome
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Points at 12 weeks
Time frame: Baseline, Week 3, Week 6 and Week 12
(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
Time frame: Week 3, Week 6, Week 9, Week 12
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
Time frame: Week 3, Week 6, Week 9, Week 12
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.
4 secondary outcomes
Change from Visual Analogue Scale(for Pain) Points at 12 Weeks
Time frame: Baseline, Week 3, Week 6 and Week 12
Change from Tampa Scale for Kinesiophobia Points at 12 Weeks
Time frame: Baseline, Week 3, Week 6 and Week 12
Change from Timed Up&Go Test Score at 12 Weeks
Time frame: Baseline, Week 3, Week 6 and Week 12
Change from Timed 10 Meter Walk Test Score at 12 Weeks
Time frame: Baseline, Week 3, Week 6 and Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High Dosage Home Exercise Training and Standard Dosage Home Exercise Training in people with Knee Osteoarthritis, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Points at 12 weeks (time frame: Baseline, Week 3, Week 6 and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.