Osteoarthritis, KneeNCT02901964
Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial
A study testing Hip Abductor Exercise and Hip Aductor Exercise in people with Osteoarthritis, Knee, run by Universidade Federal do Ceara at 1 site in Brazil.
Trial summary
Osteoarthritis (OA) is a prevalent disease associated with significant morbidity and is one of the most common causes of joint pain. Characterized by their chronicity, slow and progressive evolution. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Hip Abductor Exercise and Hip Aductor Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2016to Nov 2018
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OA knee radiograph grades 2 - 4 according to the Kellgren-Lawrence scale;
- Reporting knee pain with minimum intensity of 3 on Numerical Pain Scale;
- Complaints of pain and functional reduction in the last three months;
- Meet at least one of the American College of Rheumatology classification criteria;
- Deambulation independent;
- Absence of prostheses or orthoses
- Predominant pain in the medial aspect of the knee.
Who cannot join
- Contraindications for physical exercises evaluated by the Physical Activity Readiness Questionnaire (PAR-Q);
- Diabetes type I or decompensated;
- Hypertension decompensated;
- Cardiac pacemaker;
- Cancer History
- Neurological deficits (sensory or motor)
Show all 11Show fewer
- Body mass index above 40 kg / m2
- Hip symptomatic osteoarthriti
- Orthopedic surgery of the lower limbs
- Systemic inflammatory disease
- Can not walk.
Trial locations and contacts
1 site in 1 country.
About this study
Osteoarthritis (OA) is a prevalent disease associated with significant morbidity and is one of the most common causes of joint pain. Characterized by their chronicity, slow and progressive evolution. The overall prevalence of symptomatic knee osteoarthritis is estimated at 3.8%, with peak prevalence in the population with an average age of 50 years. The main objectives of interventions in patients with knee OA are reduced pain and improved functional capacity and exercises are widely recommended. The literature shows a lack of clinical trials verifying the effect of strengthening the hip muscles in patients with knee osteoarthritis. Thus, the aim of this study is to assess the effect of strengthening the hip abductor muscles versus hip adductor muscles in patients with symptomatic OA of the knee.
Read the detailed description
The physical therapy sessions will average duration of one hour, often twice a week for six weeks. The exercise intensity will be monitored by the physiotherapist as determined by the participant's ability to complete 10 repetitions for a particular exercise and its difficulty of execution perceived by the modified Borg scale (CR-10). The exercises are performed with load between 60-80% of their capacity, the load will be increased from 2 to 10% when the patient can perform 14 full repetitions in the last series (76). It will be set to 30 seconds of rest between reps and 2 minutes between sets of exercise.
Both groups will perform prior heating exercises exercise bike for 10 minutes with moderate intensity with the Borg scale. Then there will be two stretches repetitions held for 30 seconds of muscle groups: hamstrings, quadriceps, abductors, adductors and gastrocnemius. Manual therapy for patellofemoral and tibiofemoral joint will be held after the completion of stretching. Recent clinical guidelines on knee OA strongly recommend the use of strengthening exercises of the lower limbs, both in closed kinetic chain and open. Thus, they will be performed strengthening exercises in extension and knee flexion in open kinetic chain, squat up and down a step and exercises to sural triceps. For symptom control during exercise in CKC will be used the numeric scale of pain before and after its execution.
The GABQ add the hip abduction exercises in lateral decubitus, exercise "Clam" and pelvic elevation. Studies prior point out that these exercises are among those with higher electromyographic activity of the gluteus medius muscle.
The GADQ add the adduction exercises hip in lateral recumbency, bilateral adduction with a ball between the legs and functional diagonal leg.
The exercises will be carried out to load 60-80% of 1 repetition maximum 8-12 reps, 1-3 sets and 2-3 times a week. All exercises are performed without worsening pain and intensity of exercise will be controlled according to the perceived exertion scale of Borg.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Hip Abductor Exercise, Hip Aductor Exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip Abductor ExerciseOther
12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip abductors.
Hip Aductor ExerciseOther
12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip aductors.
| Study group | Role | What they receive |
|---|---|---|
| Group Hip Abductor Exercise | Experimental | 12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip abductors. Receives: Other: Hip Abductor Exercise |
| Group Hip Aductor Exercise | Active comparator | 12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip aductors. Receives: Other: Hip Aductor Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Scale
Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain.
Measured: Six weeks
Pain and Function subscale - Knee Injury and Osteoarthritis Outcome Score
Pain and Function subscale - KOOS was assessed, where 0 corresponded to no pain and normal function and 100 corresponded to worst pain and function.
Measured: Six weeks
Secondary outcomes (7)
Others subscales - Knee Injury and Osteoarthritis Outcome Score
Measured: Six weeks
30 s Chair Stand Test
Measured: Six weeks
Timed Up & Go Test
Measured: Six weeks
Global Perceived Effect Scale
Measured: Six weeks
Numeric Pain Scale
Measured: Six months
Knee Injury and Osteoarthritis Outcome Score
Measured: Six months
Global Perceived Effect Scale
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara
- Investigators
- Gabriel Peixoto Leão Almeida, PhD student, Principal investigator, Federal University of Ceará (UFC), Brazil.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901964
- Sponsor's protocol ID
- Doutorado
- Status last verified
- Oct 2018
- First submitted
- 5 Sep 2016
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02901964
- Acronym / sponsor ID
- Doutorado
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- May 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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.
Osteoarthritis (OA) is a prevalent disease associated with significant morbidity and is one of the most common causes of joint pain. Characterized by their chronicity, slow and progressive evolution. The overall prevalence of symptomatic knee osteoarthritis is estimated at 3.8%, with peak prevalence in the population with an average age of 50 years. The main objectives of interventions in patients with knee OA are reduced pain and improved functional capacity and exercises are widely recommended. The literature shows a lack of clinical trials verifying the effect of strengthening the hip muscles in patients with knee osteoarthritis. Thus, the aim of this study is to assess the effect of strengthening the hip abductor muscles versus hip adductor muscles in patients with symptomatic OA of the knee.
Detailed description
The physical therapy sessions will average duration of one hour, often twice a week for six weeks. The exercise intensity will be monitored by the physiotherapist as determined by the participant's ability to complete 10 repetitions for a particular exercise and its difficulty of execution perceived by the modified Borg scale (CR-10). The exercises are performed with load between 60-80% of their capacity, the load will be increased from 2 to 10% when the patient can perform 14 full repetitions in the last series (76). It will be set to 30 seconds of rest between reps and 2 minutes between sets of exercise.
Both groups will perform prior heating exercises exercise bike for 10 minutes with moderate intensity with the Borg scale. Then there will be two stretches repetitions held for 30 seconds of muscle groups: hamstrings, quadriceps, abductors, adductors and gastrocnemius. Manual therapy for patellofemoral and tibiofemoral joint will be held after the completion of stretching. Recent clinical guidelines on knee OA strongly recommend the use of strengthening exercises of the lower limbs, both in closed kinetic chain and open. Thus, they will be performed strengthening exercises in extension and knee flexion in open kinetic chain, squat up and down a step and exercises to sural triceps. For symptom control during exercise in CKC will be used the numeric scale of pain before and after its execution.
The GABQ add the hip abduction exercises in lateral decubitus, exercise "Clam" and pelvic elevation. Studies prior point out that these exercises are among those with higher electromyographic activity of the gluteus medius muscle.
The GADQ add the adduction exercises hip in lateral recumbency, bilateral adduction with a ball between the legs and functional diagonal leg.
The exercises will be carried out to load 60-80% of 1 repetition maximum 8-12 reps, 1-3 sets and 2-3 times a week. All exercises are performed without worsening pain and intensity of exercise will be controlled according to the perceived exertion scale of Borg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Hip Abductor Exercise | Experimental | Other: Hip Abductor Exercise12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip abductors. |
| Group Hip Aductor Exercise | Active comparator | Other: Hip Aductor Exercise12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip aductors. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- OA knee radiograph grades 2 - 4 according to the Kellgren-Lawrence scale;
- Reporting knee pain with minimum intensity of 3 on Numerical Pain Scale;
- Complaints of pain and functional reduction in the last three months;
- Meet at least one of the American College of Rheumatology classification criteria;
- Deambulation independent;
Key exclusion criteria (11 listed)
- Contraindications for physical exercises evaluated by the Physical Activity Readiness Questionnaire (PAR-Q);
- Diabetes type I or decompensated;
- Hypertension decompensated;
- Cardiac pacemaker;
- Cancer History
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 |
|---|---|---|
| Hip Abductor Exercise12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip abductors. | Other | Group Hip Abductor Exercise |
| Hip Aductor Exercise12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip aductors. | Other | Group Hip Aductor Exercise |
Primary outcome
Numeric Pain Scale
Time frame: Six weeks
Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain.
Pain and Function subscale - Knee Injury and Osteoarthritis Outcome Score
Time frame: Six weeks
Pain and Function subscale - KOOS was assessed, where 0 corresponded to no pain and normal function and 100 corresponded to worst pain and function.
7 secondary outcomes
Others subscales - Knee Injury and Osteoarthritis Outcome Score
Time frame: Six weeks
30 s Chair Stand Test
Time frame: Six weeks
Timed Up & Go Test
Time frame: Six weeks
Global Perceived Effect Scale
Time frame: Six weeks
Numeric Pain Scale
Time frame: Six months
Knee Injury and Osteoarthritis Outcome Score
Time frame: Six months
Global Perceived Effect Scale
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Individual participant dataSharing planned: No. IPD will not be shared.
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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.
Gabriel Peixoto Leão Almeida, PhD student principal investigator
Federal University of Ceará (UFC), Brazil.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Abductor Exercise and Hip Aductor Exercise in people with Osteoarthritis, Knee, run by Universidade Federal do Ceara at 1 site in Brazil.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numeric Pain Scale (time frame: Six weeks). The study lists 2 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 2 Nov 2018.