The Effect of Exercise Combination on Pain, Function and Proprioception in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

The Effect of Exercise Combination in Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05054686
• Other study ID #: IstanbulUCSEDA
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: April 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will include 3 different groups of intervention. First group of knee osteoarthritis patients will be applied both strengthening and 30 minutes bicycle exercises in the same session, 2 days strecthing exercises and 30 minutes walking will be given in seperate days as home program, Second group of knee osteoarthritis patients will be applied both stretching and 30 minutes bicycle exercises in the same session, strengthening exercises and 30 minutes walking will be given in seperate days as home program.Third group of knee osteoarthritis patients will be applied all stretching, strengthening and 30 minutes bicycle exercises in the same session, only 30 minutes walking will be given as home program. The primary outcome measures include the pain, function and the secondary outcome measures include the joint proprioception. The aim of this study is to investigate the effects on outcome measures increasing number of exercises in one session and to determine which exercise types are more suitable to prescribe as a home program.

Description:

This study will include 3 different groups of intervention. First group of knee osteoarthritis patients will be applied both strengthening and bicycle exercises in the same session and strecthing exercises and walking will be given as home program in the days other than treatment session. Second group of knee osteoarthritis patients will be applied both stretching and bicycle exercises in the same session and strengthening exercises and walking will be given as home program in the days other than treatment session. Third group of knee osteoarthritis patients will be applied all stretching, strengthening and bicycle exercises in the same session and only walking exercise will be given as home program in the days other than treatment session. The primary outcome measures include the pain, function and the secondary outcome measures include the joint proprioception and aerobic capacity. The aim of this study is to investigate the effects increasing number of exercises in one session on outcome measures consisting of pain, function and proprioception. The pain will be evaluated both subjectively with numeric pain scale and WOMAC scale and objectively with pressure algometer. The function will be subjectively evaluated with WOMAC scale and objectively by measuring the knee joint range of motion and muscle strength for both flexor and extensor muscles. The evaluation of joint proprioception will be evaluated with inclinometer. The aerobic capacity will be objectively evaluated with 6 minute walk test. All the groups will be treated 2 days per week. The duration of total treatment lasts 8 weeks. All the groups practice aerobic exercises 2 days with bicycle ergometer application in the clinic, and 2 days walking outside as home program. Strecthing exercises will be applied for knee flexor and knee extensor muscles. Isometric strengthening exercises will be applied for knee extensor muscles. Isotonic strengthening exercises will be applied for hip abductor muscles, hip extensor muscles, hip flexor muscles, knee flexor muscles and knee extensor muscles. The treatment outcomes will be evaluated both at the beginning of treatment and at the end of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 73 Years

Eligibility

Inclusion Criteria:

• Being diagnosed as knee osteoarthritis
• Being between the ages 45-74
• Being at stage 2-3 according to Kellegren Lawrence Classification
• Having body mass index lower than 30
• Being volunteer for participation to this study

Exclusion Criteria:

• Refusing to participation to study
• Having another orthopeadic problem ralated to lower extremity
• Having uncontrollable hypertension
• Having arterial and venous disease
• Having neurological disease
• Having perceptual problem
• Having cardiac pacemaker
• Participation to physiotherapy program in the last 6 months for the same extremity
• Taking injection from the same extremity in the last 6 months

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Stretching and Aerobic Exercise at Clinic
In this group of knee osteoarthritis patients will be applied both stretching and 30 minutes bicycle exercises in the same session, strengthening exercises and 30 minutes walking will be given in seperate days as home program.
• Strenghthening and Aerobic Exercise
In this group of knee osteoarthritis patients will be applied both strengthening and 30 minutes bicycle exercises in the same session, 2 days strecthing exercises and 30 minutes walking will be given in seperate days as home program.
• Strengthening, Stretching and Aerobic Exercises at clinic
In this group of knee osteoarthritis patients will be applied all stretching, strengthening and 30 minutes bicycle exercises in the same session, only 30 minutes walking will be given as home program.

Locations

Country	Name	City	State
Turkey	Seda Baktir	Küçükçekmece	Alkent 2000, Büyükçekmece/Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Western Ontario and McMaster Universities Arthritis Index	The Western Ontario and McMaster Universities Arthritis Index is a questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright; Stiffness (2 items): after first waking and later in the day; Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.; The increasing scores reflect improvement of the function.	Change of The Western Ontario and McMaster Universities Arthritis Index scores from the beginning to the end of study (8 weeks)
Primary	Numeric Pain Rating Scale	The Numeric Pain Rating Scale is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 likert type integers) that best reflects the intensity of his/her pain.The levels of pain felt at rest / activity / night will be evaluated. The increase in pain scores demonstrate that the health status get worse.	Change of Numeric Pain Rating Scale scores from the beginning to the end of study (8 weeks)
Primary	Pain Pressure Treshold (PPT)	Pain Pressure Treshold is evaluated via algometric measurement that were taken from 4 point including the mid portion of patella, 3 cm medial to patellar midline, 3 cm lateral to patellar midline, 2 cm above to patellar upper boundary.The increase in algometric measurement demonstrate the development in the pain sensitivity.	Change of Pain Pressure Treshold measurements from the beginning to the end of study (8 weeks)
Primary	Range of Motion at knee joint both in flexion and extension	Range of motion is evaluated by using electronic goniometer for knee flexion and knee extension angles at the beginning and end of treatment. Increase in Range of Motion values of knee joint reflects the improvement of knee joint mobility.	Change of Range of Motion measurements from the beginning to the end of study (8 weeks)
Primary	Muscle strength for knee flexor and extensor muscles	Knee joint muscle strength was measured by using hand-held dinamometer. The measurements had taken for quadrieps and hamstring muscles. the incresing muscle strength values reflects improvement of strength of muscles around knee joint.	Change of muscle strength measurements from the beginning to the end of study (8 weeks)
Secondary	Proprioception	Proprioception will be evaluated with digital inclinometer from 90 degree knee flexion to 30 degree knee flexion angle. The deviation from this interval reflects that the detoriation of knee joint proprioception. Therefore, decreasing deviation scores obtained from the inclinometer reflects better proprioceptive sensation.	Change of Inclinometric measurements from the beginning to the end of study (8 weeks).
Secondary	Aerobic Capacity	"6 Minute Walk Test'' is used for evaluation of Aerobic Capacity. The object of this test is to walk as far as possible for 6 minutes. Participants will walk back and forth in this hallway. Six minutes is a long time to walk, so participants will be exerting herself/himself. Participants will probably get out of breath or become exhausted. Necessary time should be permitted to herself/himself to slow down, to stop, and to rest. Participants may lean against the wall while resting, but resume walking as soon as possible. The increase in distance that it is walked in 6 minutes means that the aerobic capacity was developed.	Change of 6 Minute Walk Test from the beginning to the end of study (8 weeks)