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Study design
The study conducted a prospective randomized control trial. All baseline and final assessments were performed at the Rehabilitation Department of Huadong Hospital, affiliated with Fudan University Shanghai, China.
We calculated the sample size based on the muscle strength findings in the lower limbs of OA participants, using a medium effect size of 0.31, ɑ of 0.05, and power of 0.95 [19, 20]. The minimum sample size required was 36 participants. Furthermore, regarding the 10% dropout rate, at least 40 participants were enrolled for this study.
Participant selection
In this study, patients with medial compartmental KOA fulfilling American College of Rheumatology classification criteria were included. Other inclusion criteria were as follows: older than 60 years and have signed informed consent for the study. Further, the exclusion criteria were as follows: 1) received other hip or knee training over the past four weeks; 2) had a history of oral hormone therapy in the past four weeks or a history of intra-articular hormone injections in the past three months; 3) had a hip or knee replacement surgery or another type of hip or knee surgery; 4) Body Mass Index > 36; and 5) accompanied by comorbidities that may affect physical activity, such as neurological and bone, joint, and muscle diseases.
Patient recruitment
Sixty-seven participants were selected for this study, of which 25 participants were unable to meet the inclusion or exclusion criteria. Finally, 42 participants were enrolled in the study, as shown in Fig. 2. Computer randomly generated a number ranging from one to 42 for each patient; there was no overlapping between the numbers given to the patients. Then, the patients were randomly divided into two groups by simple randomization according to the ratio of 1:1. A staff who was not involved in other parts of the trial completed the randomization before the intervention in the Huadong Hospital. These numbers were put inside sealed and opaque envelopes. Research staff in the hospital then opened the envelope. Per-protocol analysis was performed in the study.
Intervention
All treatment and exercises were completed in the outpatient clinic at the Huadong Hospital under the supervision of physiotherapists to ensure standardization. A total of two physiotherapists with a mean of six years of clinical experience performed the intervention. The physiotherapists all underwent a one-week training and standardization process.
All participants were engaged in the general rehabilitation treatment for KOA participants, including health education, shortwave, low-level laser therapy, and quadriceps strengthening. The AH group performed hip exercises in addition to the general rehabilitation treatment.
Health education
All participants were encouraged to lose weight by dietary intervention; they were informed in detail about the suggested diet plan, the natural course for patients with KOA and about the way how to protect the knee joint.
Shortwave
Electrodes were placed symmetrically on the anterior–posterior knee joint; the treatment was performed at the power of 15 W for 20 min once per day, three times per week for six weeks.
Low-level laser therapy
Low-level laser therapy was used to irradiate the most painful area, usually in the anterior region of the knee, for eight minutes once per day, three days per week for six weeks.
Quadriceps strengthening
The study included the isometric quadriceps contraction training, as shown in Fig. 1B. The knee joint to be tested used 60–80% maximal voluntary isometric contraction (MVIC) to extend the knee, maintaining it for 10-s. Each repetition was separated by a 10-s rest. The training was repeated 10 times in one group, three groups per day, five times per week for six weeks.
Testing and training position for hip exercises and quadriceps strengthening. A Hip muscle training and measurement were completed in the sitting position with the self-developed hip muscle testing and training device tied at 2 cm proximal to the knee joint. Participants performed isometric hip strength training by accomplishing hip abduction and adduction movements. The maximum hip adduction MVIC was displayed on the device screen when participants were squeezing the device by their legs on the inside. Similarly, the maximum hip abduction MVIC was displayed on the device screen when participants were pulling the device by their legs on the outside. B Participants completed quadriceps strengthening by taking the sitting position. During exercises, the testing device was fixed above the ankle joint. The maximum knee extensor strength was displayed on the device screen when participants extended their legs forward. The maximum knee flexor strength was displayed on the device screen when participants squeezed the machine backward
The hip exercises
Participants took a sitting position and flexed the hip and knee joints at an angle of 90°. Hip muscle exercise was completed before quadriceps strengthening. The two ends of the self-developed hip muscle testing and training device evolved from KAPU dynamometers (KAPU, Germany) were fixed on the opposite lower thighs on both sides, as shown in Fig. 1A. Participants first squeezed the instrument on the inside and then pulled the instrument outward to perform hip adductor and abductor exercises. Each action was performed for 10-s, using 60 – 80% of maximal voluntary isometric contraction. There was a 10-s rest between actions. The training was repeated six to ten times in one group, three groups per day, five times per week for six weeks.
Outcome scores
The main outcomes were knee extension and flexion strength, hip abductor and adductor strength; the secondary outcomes included the Five Times Sit-to-Stand Test (FTSST), the Timed Up and Go Test (TUGT), Numerical Rating Scale (NRS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. All data were tested before and after the six-week treatment. The data were collected by another experienced assessor with more than three years of clinical experience blinded to group allocation. The physiotherapist underwent a one-week training and standardization process.
Muscle strength test
As mentioned above, the primary outcome of this study included knee extension and knee flexion, hip abductor and hip adductor isometric strength. The MVIC was recorded in Newtons (N). At the knee flexed to 90°, a self-developed hip muscle testing and training device was tied 2 cm proximal to the knee joint, as shown in Fig. 1A. The maximum hip adductor MVIC was displayed on the device screen when patients were squeezing the device by their legs on the inside. The maximum hip abductor MVIC was displayed on the device screen when participants were pulling the device by their legs on the outside. Knee extension and knee flexion force were tested in the same position, but the device was tied above the participants’ ankle joint, as shown in Fig. 1B. Each participant performed the maximal isometric contraction to obtain knee extension and knee flexion force. The maximal effort was ensured through verbal encouragement.
FTSST
In the elderly, the FTSST result has a strong relationship with lower-limb strength and functionality since it includes a common activity people perform daily [21, 22]. Participants sat on an armless chair, with a sitting part at the height of 43 cm. Participants were required to place their feet on the floor and cross their hands on their chests. Their backs should not recline or attach to the back of the chair. After hearing the command to start the test, participants should stand up and then sit down five times at the fastest speed they could achieve. Then, the time it took for participants to perform the entire course was recorded. During the test, participants were continuously given verbal encouragement when necessary but were not helped in performing the exact test action [23]. The test was repeated three times with breaks of 30 s; the results were averaged and saved as a final result.
TUGT
According to Shimada et al., [24] the TUGT is strongly associated with the walking speed of elderly women with KOA. When the time to complete the TUGT is shorter, participants have higher functional mobility and a lower risk of falling [25]. In this test, participants sat on an armchair with a sitting part at the height of 46 cm. In addition, a marker or brightly colored ribbon was used to make a mark on the ground 3 m away from the chair to ensure that participants could see it. After the command “start” was given, participants immediately stood up from the chair, walked forward 3 m (till they reached the marked place) at the fastest speed they could achieve, and then turned to sit back on the chair. The time between the command to start was given until participants returned and sat on the chair was recorded [26]. This test was performed twice, and the average result was saved as a final result.
NRS
The NRS has been commonly used to assess pain intensity. In this test, a straight line was equally divided into 10 parts, and a total of 11 numbers from zero to 10 were used to indicate different pain levels in patients [27]; zero indicated no pain, and 10 indicated pain that was too severe to endure. Participants were asked to provide a mark on the horizontal line according to their subjective feelings to describe the pain level. The NRS had high responsiveness and was convenient for recording [28].
WOMAC score
The WOMAC is a scoring scale specially developed for hip and knee osteoarthritis. Its function description is mainly focused on the lower limbs [29]. The WOMAC score is typically given based on participants’ clinical symptoms and the corresponding signs to assess the severity of the disease and the efficiency of treatment. In this study, the WOMAC scale was used to evaluate the functional status of lower extremities suffering from KOA by assessing 17 functional ADLs, five pain-related activities, and two stiffness categories [30]. The WOMAC index referred to 24 parameters, including pain (score range 0–20), stiffness (score range 0–8), and functionality (score range 0–68); it should be noted that higher scores indicated worse symptoms. The research of Symond [31] has shown that the WOMAC scale is widely used in the function of Chinese KOA participants due to its objective reliability, validity, and sensitivity.
Adherence to treatment was assessed by the total number of treatment sessions performed in 6 weeks. Adverse effects and adherence were recorded by physiotherapists.
Statistical analyses
Statistical analyses were conducted using SPSS 20 (IBM SPSS Inc., Chicago, USA). In the first step, we tested to see if continuous variables were normal (Shapiro–Wilk normality test), and they were expressed in the form of \(\overline{x }\)(s), indicating mean (standard deviation). The Shapiro–Wilk normality test was performed when the variance was homogeneous; otherwise, the difference between post- and pre-treatments was determined by an independent sample t-test to reduce the calculation error. We adopted the per-protocol analysis. A two-sided 2-sample unpaired t test was performed to compare the difference in mean change scores of hip abductor and adductor strength, knee extension and flexion strength, FTSST, TUGT, NRS, and WOMAC scores between AH and GT groups. Data on counts like female were expressed as n (%) and compared by the Chi-square test, and a difference of P < 0.05 was considered statistically significant.
Funding source role
The funders played no role in the design, conduct, or reporting of this study.
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