Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06160297 |
| Other study ID # |
Hkumeodabasioglu001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 18, 2021 |
| Est. completion date |
September 30, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
Hasan Kalyoncu University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
. This study was carried out to examine the effects on walking, physical function and quality
of life. There were 88 individuals in the study and they were divided into three groups as
Modified Otago, Neuromuscular and Control groups. Traditional physiotherapy applications
(Hotpack + Ultrasound (US) + Transcutaneous Electrical Nerve Stimulation (TENS) were applied
to all groups. In addition to these applications, Modified Otago and Neuromuscular exercises
were performed 2 days a week in a clinical setting, accompanied by a physiotherapist for 12
weeks. The control group was only followed up. Patients were evaluated for basic parameters
before and after treatment: Berg Balance Scale (BBS) and Timed Up Go Test (TUG) for balance
and fall risk, International Fall Efficiency Scale (FES-I) for fear of falling, Western
Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for symptoms and function,
Tampa Kinesiophobia Scale (TKS) for kinesiophobia, 6-minute walk test for functional capacity
(6MWT), Nottingham Health Profile (NHP) for quality of life, McGill Short Form (MSF)
questionnaire for pain, an android-based smartphone application called "Gait Analyzer" were
used for spatio-temporal variables in gait. Joint position sense (JPS) was measured with a
goniometer and knee flexion was determined as 30° and 60° target angles. The exercise
experiences of the groups who exercised after the treatment were evaluated by asking three
questions with answers ranging from 0 to 10. It was observed that modified Otago and
Neuromuscular exercises reduced the risk of falling and fear of falling, increased balance,
decreased clinical symptoms and pain, increased function and quality of life, provided
positive changes in the spatio-temporal parameters of walking and partially improved the
sense of joint position compared to the control group (p<0,05). When the exercise groups were
compared, the Modified Otago group had more positive quality of life and pain than the
Neuromuscular exercise group (p<0.05). In addition, individuals in this group evaluated the
exercises as less boring and less tiring (p<0.001). Modified Otago and Neuromuscular
exercises can be included in the treatment programs of individuals with geriatric knee
osteoarthritis as exercises aimed at reducing possible falls. It was concluded that Modified
Otago exercises are superior and therefore more preferable in terms of compliance and
satisfaction of individuals.
Description:
This study was conducted to geriatric individuals diagnosed with knee osteoarthritis who
applied to T.R. Ministry of Health Kilis Prof. Dr. Alaeddin Yavaşca State Hospital Department
of the Physical Therapy and Rehabilitation. 88 individuals who volunteered to participate in
the study were included in the study. Individuals were evaluated in terms of basic parameters
and 3 randomized groups were formed: Modified Otago exercise group (29), neuromuscular
exercise group (29) and control group (30).
The study protocol was approved by Hasan Kalyoncu University Ethics Committee (No: 2021/073,
31.05.2021). Individuals were informed about the scope, duration, treatment and evaluations
of the study.
The study was planned as prospective, single-blind and randomized controlled. Patients
underwent a preliminary evaluation by a physiotherapist to determine compliance with the
inclusion criteria. The numbers were randomly distributed on the website www.random.org,
which offers random numbers for many purposes. Patients whose eligibility was determined were
then assigned to one of these groups in the order of arrival. The groups were determined as
Group-1 Modified Otago Exercise Group (MOEG), Group-2 Neuromuscular Exercise Group (NEG) and
Group-3 Control Group (CG).
Initially, traditional physiotherapy applications (Hotpack + US (Ultrasound) + TENS
(Transcutaneous Electrical Stimulation) were applied to each group, and after these
applications, each group was evaluated in terms of basic parameters.
In addition to these practices, the exercise groups were given modified otago and
neuromuscular exercises in the clinic, 2 days a week, under the supervision of a
physiotherapist, for 12 weeks. KG was not intervened.
Patients were evaluated for basic parameters before and after treatment. Berg Balance Scale
(BBS) and Timed Up and Go Test (TUG) for balance and fall risk in individuals, International
Fall Activity Scale (FES-I) for fear of falling, Western Ontario and McMaster Universities
Osteoarthritis Index (WOMAC) for disease-specific symptoms and functional status, Tampa
Kinesiophobia Scale (TKS) for kinesiophobia, 6-minute walk test (6MWT) for functional
capacity, Nottingham Health Profile (NHP) for quality of life, McGill Short Form (MSF)
questionnaire for pain, "Gait Analyzer" for spatio-temporal variables of gait that an
android-based smartphone application called was used. For joint position sense (EPH), 30° and
60° knee flexion were determined as target angles and measurements were made with a
goniometer.
At the end of 12 weeks, all groups were re-evaluated in terms of basic parameters.
Functional Status Assessment: The Western Ontario and McMaster Universities Osteoarthritis
Index (WOMAC) is a self-reported health status measure developed to assess pain, joint
stiffness, and function that is widely used in patients with hip and knee osteoarthritis. It
questions patients clinically about three different dimensions: pain, joint stiffness and
function in the last 24 hours. Questions are in a 5-point Likert format and are scored
between 0-4 (0: none, 1: mild, 2: moderate, 3: severe, 4: very severe). It contains a total
of 24 questions: 5 assessing pain, 2 assessing stiffness, and 17 assessing function. The
three subscales that make up the scale can be scored separately or as a total. Higher scores
represent worse pain, physical function, and stiffness.
Balance and Fall Risk Assessment:
Berg Balance Scale (BBS): BBS is used to evaluate an adult's balance abilities while
performing functional tasks. Some functional activities such as standing up from a sitting
position, standing without support, standing on one leg, various turning activities, standing
with eyes closed, and chair transfers are evaluated. The scale consists of 14 items in Likert
format and performances are scored as five different points (0-4), ranging from 0 "cannot do"
to 4 "does independently and safely". The total score is between 0 and 56 points. The closer
this value is to 0, the higher the risk of falling. According to the total score obtained
from this test, if the risk of falling is between 0-20 points, it is considered as "high
risk", if it is between 21-40 points, it is considered as "medium risk", and if it is between
41-56 points, it is considered as "low risk". Patients with moderate fall risk were included
in our study.
Timed Up and Go Test (TUG): Recommended by the American Geriatrics Society and the British
Geriatrics Society to screen for fall risk. This test was used to determine functional
mobility and fall risk. For the test, patients were asked to sit on a chair. A target point
was determined 3 meters away from the chair. Patients were instructed to stand up, walk to
this target at a steady and normal walking speed, then return and sit on the chair. The time
between the patients getting up from the chair and sitting back down was measured with a
stopwatch. The patients made the first trial for learning and the second trial was recorded
in seconds as the real test.
Assessment of Fear of Falling: (Falls Efficacy Scale - International FES-I): International
Falls Efficacy Scale is a 16-question self-reported scale that aims to obtain information
about individuals' anxiety levels regarding falls while performing daily life activities. The
questions are in Likert format and are scored as 4 points (1-4), from 1 "I am not worried at
all" to 4 "I am very worried". The total score varies between 16-64 points, and the closer
this score is to 64, the higher the fear of falling.
Assessment of Kinesiophobia: Kinesiophobia is a condition in which a patient has an
excessive, irrational, and debilitating fear of physical activity and movement resulting from
a painful injury or a feeling of vulnerability to re-injury. To evaluate individuals'
kinesiophobia, the Tampa Kinesiophobia Scale, whose Turkish reliability and validity has been
established, was used. The scale is in a four-point Likert format (1-totally disagree,
4-totally agree) and consists of 17 questions. While calculating the scale score, the scores
of some questions (4, 8, 12 and 16) are reversed and calculated. A high total score indicates
that the individual has high kinesiophobia.
Functional Capacity Evaluation: Functional capacity evaluation of individuals was carried out
with the 6-minute walk test (6MWT). 6MWT not only evaluates the patient's walking ability but
also gives an indication of the individual's endurance level. Therefore, it is an excellent
functional outcome measure for knee OA recommended by the ACR. The test is performed in a
closed and uncrowded place. In a closed area, there should be a flat surface with a distance
of 30 meters between the starting and ending points. The distance an individual can walk in
this area in 6 minutes is evaluated in meters. Before the test begins, the patient is rested
and given information about the test. The patient is asked to walk at his own walking pace
between the starting and ending points. The test is monitored with a stopwatch. The purpose
of the test is to measure the maximum distance he can walk during this time.
Assessment of Pain: Pain status of individuals was evaluated with the Turkish version of the
short form McGill pain questionnaire. The questionnaire consists of three parts and provides
information about the sensory, emotional and intensity component of pain sensation. In the
first section, there are 15 different words describing pain, and there are options in a
four-point Likert format (0-none, 1-mild, 2-moderate, 3-severe) corresponding to the
intensity of the defined pain level. The individual is asked to indicate the type and
intensity of pain he is experiencing. The first 11 questions evaluate the sensory dimension
of pain and the last 4 questions evaluate the perceptual dimension of pain. In the first
part, three different scores are obtained: sensory pain score, perceptual pain score and
total pain score. In the second part of the questionnaire, there are six different
expressions ranging from "none" to "unbearable pain" to determine the severity of the current
pain experienced by the individual. In the third part, there is a visual pain scale in the
form of a line divided into 1 cm slices to determine the severity of the individual's current
pain (no pain - 0, severe pain - 10). The individual is asked to indicate the intensity of
pain he/she experiences as requested in the second and third sections. With the third part, a
visual pain score is obtained.
Evaluation of Quality of Life: The Turkish version of the Nottingham Health Profile (NHP) was
used to evaluate individuals' perceptions of quality of life. NHP is a quality of life scale
used to measure individuals' perceived health status. It has been found to be extremely safe
for use in OA populations. The survey essentially consists of two parts. The first part deals
with 6 health-related dimensions (pain-8, physical activity-8, energy level-3, sleep-5,
social isolation-5 and emotional reactions-9) and consists of a total of 38 items. The second
part consists of 7 items. Individuals are asked to evaluate the situations as "yes" or "no".
Each section is scored between 0-100 points and the total score is scored between 0-600
points, thus obtaining a health profile score. Low scores indicate a good health profile,
high scores indicate a poor health profile.
Joint Position Sense: Joint position sense (JPS) is evaluated by the angular difference
between a repeatedly determined target position and the predicted position, and this is
called absolute angular error. This method is a reliable technique for the knee joint. JPS is
tested by actively finding the joint position that was previously taught passively. In the
study, only the knee joint was evaluated for JPS and 30° and 60° knee flexion were determined
as target angles. A universal goniometer was used for testing. Before the measurement,
individuals were given information about the test. For the test position, individuals were
placed in a sitting position with their hips and knees flexed at 90° and their feet elevated
from the ground. Then, while the knee was slowly brought from 90° flexion to passive
extension, it was first stopped at 60° flexion angle for 5 seconds and the individuals were
asked to perceive and learn this position. Then, the measurement was made by asking the
individual to bring his knee to this target angle. The difference was recorded as absolute
angular error. The same process was performed for the 30° flexion angle. Three repetitions
were requested for both positions and the averages were calculated and recorded. Individuals
used an eye patch to eliminate visual feedback while testing.
Evaluation of Spatio-Temporal Variables of Gait: For gait, a smartphone-based application
called "Gait Analyzer" for gait (version 0.9.95.0 (Control One LLC, NM, USA)), offered as a
paid application by the Android platform, whose reliability and validity have been
tested-retested, was used. As a result of the measurement made with this application,
kinematic data of walking such as walking speed, cadence, step time, step length, step length
symmetry and step time symmetry can be obtained. After the program was installed on the
smartphone (Huawei Mate 10 Lite, RNE-L01), some demographic data of the patient was entered.
Afterwards, the smartphone was fixed to the area corresponding to the patient's L3 proccesus
spinosus with a suitable waist belt with a velcro bandage. The measurement was then performed
by asking the patients to walk a distance of 20 meters in their natural walking style and
speed, without walking aid. The results were recorded on the form.
Assessing Exercise Satisfaction: A form with numerical scores between 0-10 was applied to the
Modified Otago and Neuromuscular exercise group at the end of 12 weeks for their exercise
experiences. The form included the following 3 questions: "Were you satisfied with the
treatment?", "Did you have difficulty doing the exercises?" and "Did you get bored doing the
exercises?".
Exercise Protocols: For both exercise models, before starting the intervention, individuals
were informed about the exercise procedures and shown in detail how to do the exercises. They
were informed that the movements should be performed correctly while the exercises were
performed, that the exercises should be accompanied by the correct breathing pattern, and
that they could rest if they felt tired. She was told to report any shortness of breath,
dizziness, or chest pain during exercise to the physiotherapist. The exercises took
approximately 20 minutes to complete and were performed 2 non-consecutive days a week in a
clinical environment, accompanied by a physiotherapist. Individuals were assigned two days a
week for exercise sessions. A make-up option was offered the same week for the days he could
not attend the session. Individuals whose participation in the program was below 75% were
excluded from the study.
Modified Otago Exercise Group (MOEG) MOEG consists of strengthening and balance exercises.
Participants were instructed to start the exercises with 5-minute flexibility exercises. The
walking component of the original Otago exercises and the stair climbing exercise in the
balance exercises were not included in the MOEG. The exercises included 5 strengthening
exercises and 11 balance exercises.
There are basically four difficulty levels in Otago exercises: A, B, C and D, from easy to
difficult. But not every exercise involves these four levels. While some exercises are
performed at a single difficulty level, some may include all four levels in the process.
While the exercises were performed, progression was made according to the individuals'
ability to achieve these difficulty levels. In general, if individuals could perform 2 sets
of 10 repetitions at a difficulty level with quality, they were moved to a higher difficulty
level. In the first two weeks of the intervention, the exercises were started from the
simplest level for all individuals so that the individuals could learn the exercises more
easily and adapt to the program.
A 1 kg free weight attached to the ankle was used as resistance in the strengthening
exercises of knee extension, knee flexion and hip abduction. In the first two weeks of the
intervention, all individuals started with 1 kg. When the movements were performed with
quality in 2 sets of 10 repetitions, the free weight was increased to 2 kg and continued in
this way for the remaining weeks. Body weight was used as resistance in dorsiflexor and
plantar flexor strengthening exercises. There were two difficulty levels in these exercises:
supported and unsupported. The progression continued in the same way, when the movements were
performed in 2 sets of 10 repetitions with high quality, they moved to a higher difficulty
level and continued at this level for the remaining weeks. In balance exercises, progression
was made by first moving from the supported position to the unsupported position, and then by
increasing the number of repetitions. When the movements were performed in a quality manner
for 2 sets of 10 repetitions, the movements were continued to a higher difficulty level, as
in the strengthening exercises.
The exercises are as follows; Warm-up exercises (5 min) Strengthening exercises (weight
attached to ankle)
- Knee extension while sitting on a chair
- Knee flexion while standing with support from a chair
- Hip abduction while standing with support from the chair Strengthening exercises (weight
removed from ankle)
- Standing on tiptoe with support from a chair
- Rising on the heels with support from a standing chair Balance Exercises (progressively,
with support - without support)
- Mini squats
- Toe walking
- Walking on heels
- Tandem stance
- Tandem walking
- Walking backwards (10 steps)
- Standing on one leg
- Assisted side walking
- Side walking without support
- Sit and stand on the chair
- Figure eight walking Neuromuscular Exercise Program Neuromuscular exercises basically
consist of four exercise components. These; core stability / postural function, postural
orientation, lower extremity muscle strength and functional exercises. Exercises also
include 5-minute warm-up and cool-down periods. Progression in neuromuscular exercises
was achieved by changing the direction and speed of the movement from simple to
difficult according to the capacities of the individuals, increasing the amount of
loading, changing the support surface and perturbation interventions. Apart from this,
the resistance bands used in strengthening exercises started with yellow color and were
switched to red, green and purple colors in the following weeks, depending on the
capacity of the individual. In general, if individuals could perform 2 sets of 10
repetitions at a difficulty level with quality, they were moved to a higher difficulty
level. In the first two weeks of the intervention, the exercises were started from the
simplest level for all individuals so that the individuals could learn the exercises
more easily and adapt to the program.
- Proprioceptive stabilization of the knee with ball
- Bridging with ball
- Stepping forward, sideways and backwards by holding on to a fixed support while standing
- Doing the same movements with the support leg on a different surface
- Hip abduction-adduction with resistance band
- Knee flexion-extension with resistance band
- Climbing and descending steps by taking steps
- Balancing on the step
- Standing up from the chair
