NCT05977374

Brief Summary

This research study is determined to see the effects of low-impact elliptical training on knee osteoarthritis outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
Last Updated

August 4, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

July 11, 2023

Last Update Submit

July 28, 2023

Conditions

Keywords

Knee osteoarthritis

Outcome Measures

Primary Outcomes (6)

  • 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.

    Baseline, 6th week and 12th week.

  • Knee joint X-rays.

    From the X-rays we will measure the medial and lateral knee joint space width through Radiant software.

    Baseline, 6th week and 12th week.

  • 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.

    Baseline, 6th week and 12th week.

  • 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.

    Baseline, 6th week and 12th week.

  • 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.

    Baseline, 6th week and 12th week.

  • 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.

    Baseline, 6th week and 12th week.

Study Arms (2)

elliptical training group.

EXPERIMENTAL

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.

Other: experimental and conventional group

Conventional treatment group

OTHER

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.

Other: experimental and conventional group

Interventions

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.

Also known as: Conventional group
Conventional treatment groupelliptical training group.

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65-year-old.
  • Diagnosed cases of Grade 1 and 2 Knee OA.
  • Healthy and overweight patients will be included. (18.5- 29.5)

You may not qualify if:

  • Acute musculoskeletal injury.
  • Low back pain and Sciatica.
  • Hip and ankle pathology.
  • Acute infection, fever.
  • The patient taking supplements and medications.
  • Any knee deformity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islamabad Physical Therapy & Rehabilitation Centre

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
one of my groups is experimental and the other one is controlled.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2023

First Posted

August 4, 2023

Study Start

December 12, 2022

Primary Completion

May 30, 2023

Study Completion

June 27, 2023

Last Updated

August 4, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations