Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04771936 |
| Other study ID # |
2395 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 28, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
University of Malta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Osteoarthritis (OA) is a common disease that occurs more commonly amongst the elderly and is
caused by the destruction of the joint cartilage. It is considered to be one of the most
common joint disorders worldwide and a main cause of disability amongst older adults. After
the knee, the hip is considered to be the second most commonly affected joint by OA. One of
the functional capacities affected by OA is muscle strength with studies looking into knee OA
documenting a decrement of this measure. It is reported that the muscle strength of the
quadriceps, hamstrings and other musculature around the hip is significantly impaired in
patients with knee OA compared to age-matched controls.
Evidence for quadriceps muscle weakness in knee OA is consistent and programs based on
quadriceps strengthening exercises as a core component in the management of knee OA are now
evidence-based. Lower extremity muscle weakness is also apparent in hip OA. However, compared
to the knee, there is less literature on muscle strength in hip OA with guidelines for
therapeutic exercise prescription being more expert rather than evidence-based. Therefore,
one of the major questions that arises here is whether muscle weakness as observed in knee OA
is evident in hip OA, and if so, which muscles are most affected.
A concept which has been found to help diminish the effect of decreased muscle strength in
the above mentioned muscle groups is optimal core stability. Core stability contributes to
strength, endurance, flexibility and motor control all of which optimise the stability of the
spine during both dynamic and static tasks in daily normal biomechanical function in patients
with a diagnosis of OA knees. Despite such evidence, no studies to the knowledge of the
researcher have looked into the effects of core stability on pain and functional levels in
patients with a diagnosis of OA hip. A lack of literature in relation to this aspect is due
to the unavailability of a gold standard for measuring core stability.
Therefore, the objective of this study will be multifold with an investigation into which
muscles in the lower limb are predominantly weaker, whether there is core muscle weakness in
patients with hip OA, looking for any correlation between both these factors and whether an
exercise programme leads to changes on functional activity and pain levels.
Description:
Osteoarthritis (OA) is a common disease that occurs more commonly amongst the elderly and is
caused by the destruction of the joint cartilage. It is considered to be one of the most
common joint disorders worldwide and a main cause of disability amongst older adults. After
the knee, the hip is considered to be the second most commonly affected joint by OA.
One of the functional capacities affected by OA is muscle strength with studies looking into
knee OA documenting a decrement of this measure. The muscle strength of the quadriceps,
hamstrings and other musculature around the hip is significantly impaired in patients with
knee OA compared to age-matched controls.
Evidence for quadriceps muscle weakness in knee OA is consistent and programs based on
quadriceps strengthening exercises as a core component in the management of knee OA are now
evidence-based. Lower extremity muscle weakness is also apparent in hip OA. However, compared
to the knee, there is less literature on muscle strength in hip OA with guidelines for
therapeutic exercise prescription being more expert rather than evidence-based. Therefore,
one of the major questions that arises here is whether muscle weakness as observed in knee OA
is evident in hip OA, and if so, which muscles are most affected.
A concept which has been found to help diminish the effect of decreased muscle strength in
the above mentioned muscle groups is optimal core stability. Core stability contributes to
strength, endurance, flexibility and motor control all of which optimise the stability of the
spine during both dynamic and static tasks in daily normal biomechanical function in patients
with a diagnosis of OA knees. Despite such evidence, no studies to the knowledge of the
researcher have looked into the effects of core stability on pain and functional levels in
patients with a diagnosis of OA hip. Lack of literature in relation to this aspect is due to
the unavailability of a gold standard for measuring core stability.
Therefore, the objective of this study will be multifold with an investigation into which
muscles in the lower limb are predominantly weaker, whether there is core muscle weakness in
patients with hip OA, looking for any correlation between both these factors and whether an
exercise programme leads to changes on functional activity and pain levels.
All the patients who give consent to participate shall be randomly assigned to three groups
being the control group who shall be awaiting surgery and not receiving a regular
physiotherapy exercise intervention, the exercise group who shall be subject to a set of
conventional exercises based and a core exercise group who shall be performing the
conventional exercises plus exercises aimed at the activation of the core muscles. These
exercises shall be carried out three times weekly for a period of three months. During the
first four weeks, all sessions shall be supervised by a physiotherapist who shall monitor and
increase the duration or difficulty of exercises according to patients' progression. From the
5th to the 8th week, patients shall attend two supervised sessions and complete the third one
at home. Between the 9th and the 12th week, patients shall then attend one supervised
intervention and complete two exercise sessions at home. All patients shall be given a copy
of the exercise sheet with instructions for use at home. Anonymisation shall be ensured with
every patient through assignment of a random code for every individual. Patients assigned to
the control group shall be given a chance to enrol into the program upon completion of the
study if they wish to do so.
