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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04925726
Other study ID # MYHY
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 10, 2018
Est. completion date October 10, 2019

Study information

Verified date June 2021
Source Afyonkarahisar Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Water-Based vs. Land-Based Rehabilitation After Arthroscopic Partial Meniscectomy in Middle-Aged Active Patients with a Degenerative Meniscal Tear: A Randomized, Controlled Study


Description:

In this study, we aimed to determine and compare the benefits of water-based exercise (WBE) and land-based exercise (LBE) on pain, functionality, and quality of life after arthroscopic partial meniscectomy (APM). Middle-aged (35-50), active 30 patients having APM for a degenerative meniscal tear randomized into LBE (n=15) and WBE (n=15) groups. The pain level (visual analogue scale [VAS]), isokinetic muscle strength, quality of life (Short Form-36 [SF-36]), and function level (single-leg hop test and Lysholm questionnaire) were evaluated prior to treatment and at follow-up visits at the fourth and eighth week after surgery. The exercise sessions were conducted 3 times a week for 4 weeks in both groups.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 10, 2019
Est. primary completion date October 10, 2019
Accepts healthy volunteers No
Gender All
Age group 35 Years to 50 Years
Eligibility Inclusion Criteria: The inclusion criteria comprised a non-locked painful knee of more than 1 month, age between 35-50 years, a clinical history and examination compatible with degenerative meniscus, positive findings of a degenerative meniscal tear visible with magnetic resonance imaging (MRI), no response to nonoperative treatment of at least 3 months after onset of symptoms, and no evidence of advanced osteoarthritis (OA) on X-rays or MRI Exclusion Criteria: The exclusion criteria employed were advanced knee OA, systemic inflammatory disease, a concurrent tear of posterior cruciate ligament, a concurrent collateral ligament repair, other problems causing knee pain (e.g., hip and ankle pathologies), a history of cardiopulmonary disease that could limit isokinetic and functional testing, an unstable medical condition, a serious cognitive deficit, a psychiatric problem, no capacity for independent walking and standing, an open wound on the skin, or pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Land based exercise
The patients who had land based exercise
Water based exercise
The patients who had water based exercise

Locations

Country Name City State
Turkey Hilal Yesil Merkez Afyon

Sponsors (1)

Lead Sponsor Collaborator
Hilal Yesil

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline VAS (visual analog scale) at 4th and 8th week The patients were asked to make an assesment of their pain level between 0 and 10 scale up to 8 weeks
Secondary Change from baseline isokinetic muscle strength at 4th and 8th week Isokinetic knee extensor muscle strength of the patients was measured with an isokinetic dynamometer. The test was repeated 10 times at the velocity of 60°/second and 180°/second and peak torque (Nm) measurements were recorded . up to 8 weeks
Secondary Change from baseline quality of life (short form 36) at 4th and 8th week The physical and mental health summary scores were the primary components used. Scoring is on a scale of 0 to 100 and a higher score reflects better health-related quality of life. up to 8 weeks
Secondary Change from baseline Single-leg hop test at 4th and 8th week The patient stands on one foot with the big toe touching a line marked on the floor. The participant asked to hop forward as far as possible using the same leg with their arms swing freely on both sides of the body. Distance is measured from the starting point to the heel of the landing leg. up to 8 weeks
Secondary Change from baseline Lysholm questionnaire at 4th and 8th week Eight subtitles are scored differently (limping or use of support: 5 points, locking sensation: 15 points, joint instability and pain: 25 points, swelling: 10 points, stair climbing: 10 points, and squatting: 5 points). The highest and optimal total score is 100 points up to 8 weeks
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