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Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
experimental and conventional group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee osteoarthritis

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 40- to 65-year-old. Diagnosed cases of Grade 1 and 2 Knee OA. Healthy and overweight patients will be included. (18.5- 29.5) Exclusion Criteria: Acute musculoskeletal injury. Low back pain and Sciatica. Hip and ankle pathology. Acute infection, fever. The patient taking supplements and medications. Any knee deformity.

Sites / Locations

  • Islamabad Physical Therapy & Rehabilitation Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

elliptical training group.

Conventional treatment group

Arm Description

In this group, Ultrasound 1MHz, 1.5W/cm2 7 mins, knee isometrics, and open chain activities. static stretching of the lower limbs will be given 10 reps each and held for 10 secs. 5 mins of warm-up activity on elliptical training will be given prior to the treatment group. then 3 mins of training with a set pace of 120 strides/min will start, then after 7 weeks, the timings will be increased to 5 mins. The base check-up will be conducted during 7 weeks and at the end of 12 weeks.

Static stretching of the lower limbs as mentioned above, Ultrasound 1MHz 1.5W/cm2 7min, knee isometrics, open chain activities, anterior-posterior Maitland knee mobilizations grade 1 and 2, and home care plan.

Outcomes

Primary Outcome Measures

Knee joint pain.
Pain is measured through KOOS questionnaire, which is the part of the KOOS and it has 9 items to identify pain scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Knee joint X-rays.
From the X-rays we will measure the medial and lateral knee joint space width through Radiant software.
Knee joint stiffness and symptoms.
This is the part of KOOS questinnaire, it involves 5 items of symptoms and 2 items of stiffnss to rule out knee joint symptoms and stiffness. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Activities of daily livings impact on knee joint
This is also the part of KOOS questionnaire, it includes 17 items to find out the scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Sports activity impact on knee joint
We can find the sports scoring through KOOS questionnaire, it embroils 5 items. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Quality of life impact on knee joint
This one is also the part of KOOS questionnaire. it contain 4 items for scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2023
Last Updated
July 28, 2023
Sponsor
Riphah International University
Collaborators
Health Education Research Foundation (HERF)
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1. Study Identification

Unique Protocol Identification Number
NCT05977374
Brief Title
Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.
Official Title
Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
June 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riphah International University
Collaborators
Health Education Research Foundation (HERF)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study is determined to see the effects of low-impact elliptical training on knee osteoarthritis outcomes.
Detailed Description
This study is designed to reduce the load of knee osteoarthritis patients in society so that the individual lives a healthy life without getting caught in any form of disability. Knee osteoarthritis is a progressive and degenerative disease of a joint that includes focal cartilage loss, bony hypertrophy, synovial capsule thickening, and changes in structures of periarticular ligaments and peripheral muscles. There are several techniques used to overcome the individual's pain, for instance, the mobilization of the joint, prolotherapy, and the use of different electrical modalities. meanwhile, an elliptical workout provides a positive result in reducing the progression of overall knee joint and cartilage defects. elliptical training is included in low-impact activities which are proven joint-friendly activities for the better improvement of the knee joint. This activity works on a similar principle of cyclic compressive loading as occurs in the manual mobilization of the knee joint. This activity brings out the fluid from the synovial membrane on compression and upon decompression, the cartilage reabsorbs the oxygen and nutrients, which crosses the synovial barrier into the synovial fluid through a double diffusion system in the joint. The fluid then reaches the extra-cellular matrix that moves to the multiple layers of chondrocytes for the growth of the cartilage in OA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Knee osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
one of my groups is experimental and the other one is controlled.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
elliptical training group.
Arm Type
Experimental
Arm Description
In this group, Ultrasound 1MHz, 1.5W/cm2 7 mins, knee isometrics, and open chain activities. static stretching of the lower limbs will be given 10 reps each and held for 10 secs. 5 mins of warm-up activity on elliptical training will be given prior to the treatment group. then 3 mins of training with a set pace of 120 strides/min will start, then after 7 weeks, the timings will be increased to 5 mins. The base check-up will be conducted during 7 weeks and at the end of 12 weeks.
Arm Title
Conventional treatment group
Arm Type
Other
Arm Description
Static stretching of the lower limbs as mentioned above, Ultrasound 1MHz 1.5W/cm2 7min, knee isometrics, open chain activities, anterior-posterior Maitland knee mobilizations grade 1 and 2, and home care plan.
Intervention Type
Other
Intervention Name(s)
experimental and conventional group
Other Intervention Name(s)
Conventional group
Intervention Description
Static stretchings of the lower limb, Ultrasound 1 MHz 1.5W/cm2 7 mins, knee isometrics, open chain activities, knee mobilizations grade 1 and 2, and home care plan.
Primary Outcome Measure Information:
Title
Knee joint pain.
Description
Pain is measured through KOOS questionnaire, which is the part of the KOOS and it has 9 items to identify pain scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Time Frame
Baseline, 6th week and 12th week.
Title
Knee joint X-rays.
Description
From the X-rays we will measure the medial and lateral knee joint space width through Radiant software.
Time Frame
Baseline, 6th week and 12th week.
Title
Knee joint stiffness and symptoms.
Description
This is the part of KOOS questinnaire, it involves 5 items of symptoms and 2 items of stiffnss to rule out knee joint symptoms and stiffness. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Time Frame
Baseline, 6th week and 12th week.
Title
Activities of daily livings impact on knee joint
Description
This is also the part of KOOS questionnaire, it includes 17 items to find out the scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Time Frame
Baseline, 6th week and 12th week.
Title
Sports activity impact on knee joint
Description
We can find the sports scoring through KOOS questionnaire, it embroils 5 items. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Time Frame
Baseline, 6th week and 12th week.
Title
Quality of life impact on knee joint
Description
This one is also the part of KOOS questionnaire. it contain 4 items for scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Time Frame
Baseline, 6th week and 12th week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 40- to 65-year-old. Diagnosed cases of Grade 1 and 2 Knee OA. Healthy and overweight patients will be included. (18.5- 29.5) Exclusion Criteria: Acute musculoskeletal injury. Low back pain and Sciatica. Hip and ankle pathology. Acute infection, fever. The patient taking supplements and medications. Any knee deformity.
Facility Information:
Facility Name
Islamabad Physical Therapy & Rehabilitation Centre
City
Islamabad
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.

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