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

Sponsor

Istanbul University-Cerrahpasa (Other)

Overall Status

Completed

CT.gov ID

NCT05054686

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Other: Stretching and Aerobic Exercise at Clinic Other: Strenghthening and Aerobic Exercise Other: Strengthening, Stretching and Aerobic Exercises at clinic	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective Parallel Group Comparison StudyProspective Parallel Group Comparison Study

Masking:

Double (Participant, Investigator)

Masking Description:

Double Blind

Primary Purpose:

Treatment

Official Title:

The Effect of Exercise Combination in Knee Osteoarthritis

Actual Study Start Date :

Jul 1, 2019

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

May 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination of Stretching and Aerobic Exercises at Clinic Combination of Stretching and Aerobic Exercises at Clinic and Strengthening and Aerobic Exercises at Home	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.
Active Comparator: Combination of Strengthening and Aerobic Exercises at Clinic Combination of Strengthening and Aerobic Exercises at Clinic and Stretching and Aerobic Exercises at Home	Other: 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.
Active Comparator: Combination of Strengthening, Stretching and Aerobic Exercises at Clinic Combination of Strengthening, Stretching and Aerobic Exercises at Clinic and Aerobic Exercises at Home	Other: 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.

Arm

Intervention/Treatment

Experimental: Combination of Stretching and Aerobic Exercises at Clinic

Combination of Stretching and Aerobic Exercises at Clinic and Strengthening and Aerobic Exercises at Home

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.

Active Comparator: Combination of Strengthening and Aerobic Exercises at Clinic

Combination of Strengthening and Aerobic Exercises at Clinic and Stretching and Aerobic Exercises at Home

Other: 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.

Active Comparator: Combination of Strengthening, Stretching and Aerobic Exercises at Clinic

Combination of Strengthening, Stretching and Aerobic Exercises at Clinic and Aerobic Exercises at Home

Other: 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.

Outcome Measures

Primary Outcome Measures

The Western Ontario and McMaster Universities Arthritis Index [Change of The Western Ontario and McMaster Universities Arthritis Index scores from the beginning to the end of study (8 weeks)]
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.
Numeric Pain Rating Scale [Change of Numeric Pain Rating Scale scores from the beginning to the end of study (8 weeks)]
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.
Pain Pressure Treshold (PPT) [Change of Pain Pressure Treshold measurements from the beginning to the end of study (8 weeks)]
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.
Range of Motion at knee joint both in flexion and extension [Change of Range of Motion measurements from the beginning to the end of study (8 weeks)]
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.
Muscle strength for knee flexor and extensor muscles [Change of muscle strength measurements from the beginning to the end of study (8 weeks)]
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.

Secondary Outcome Measures

Proprioception [Change of Inclinometric measurements from the beginning to the end of study (8 weeks).]
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.
Aerobic Capacity [Change of 6 Minute Walk Test from the beginning to the end of study (8 weeks)]
"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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 73 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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