search
Back to results

Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis (MME-KOA)

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multi-modal exercise program
Conventional treatment
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 60 years
  • Knee pain
  • Score in Kellgren-Lawrence Scale ≥1

Exclusion Criteria:

  • Unable to ambulate independently
  • Mini-mental state examination score < 24
  • Barthel Index score < 80
  • Unstable cardiovascular disease
  • Neurological disorder that could compromise exercising
  • Upper or lower-extremity fracture in the past year

Sites / Locations

  • Universidad CEU Cardenal Herrera

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental-Multi-modal exercise program

Experimental-conventional treatment

Arm Description

Each session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk,one-leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking. Finally, participants are instructed to walk at their usual pace for at least 10 minutes.

Each session (48) consist in isotonic exercises of low intensity and joint mobility of the lower extremities. These exercises are usually prescribed in medical consultations for the treatment of knee osteoarthritis.

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
It is a self-questionnaire consisting of 24 items divided into 3 sub-scales: pain (5 items): when walking on level ground, using stairs, in bed, sitting or lying down, and standing. Rigidity (2 items) morning and during the rest of the day. Functional capacity (17 items): use of stairs, getting up from sitting, standing, stooping, walking, getting in / out of a car, going shopping, putting on / taking off socks and / or socks, getting out of bed, lying on the bed, entering / leaving the shower / tub, sitting and getting up from the toilet, performing heavy and light household chores.

Secondary Outcome Measures

Numeric pain Rating Scale (NRS)
The NRS is a one-dimensional measure of pain intensity. The format is a line in which the participant selects a number between 0-10 that best reflects the intensity of the pain itself. A higher value corresponds to a greater intensity of pain.
Timed 10-Meter Walk Test (10-MWT)
It is a test for the evaluation of the usual and maximum gait speed along a distance of 10 meters corridor.
6-Minute Walk Test (6-MWT)
It is a test that evaluates the maximum distance a participant can walk during 6 minutes along a 30 meter long corridor.

Full Information

First Posted
May 14, 2019
Last Updated
December 10, 2019
Sponsor
Cardenal Herrera University
search

1. Study Identification

Unique Protocol Identification Number
NCT03951506
Brief Title
Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis
Acronym
MME-KOA
Official Title
Effects a Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 26, 2019 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

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
Aim: To evaluate the short-term effects of a multi-modal exercise program on physical performance variables in older adults with knee osteoarthritis.
Detailed Description
Aim: To evaluate the short-term effects of 16 week multi-modal exercise program on physical performance variables in independent community-dwelling older adults with knee osteoarthritis. Design: randomized controlled trial. Setting: home-based intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental-Multi-modal exercise program
Arm Type
Experimental
Arm Description
Each session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk,one-leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking. Finally, participants are instructed to walk at their usual pace for at least 10 minutes.
Arm Title
Experimental-conventional treatment
Arm Type
Experimental
Arm Description
Each session (48) consist in isotonic exercises of low intensity and joint mobility of the lower extremities. These exercises are usually prescribed in medical consultations for the treatment of knee osteoarthritis.
Intervention Type
Other
Intervention Name(s)
Multi-modal exercise program
Intervention Description
Each session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk,one-leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking. Finally, participants are instructed to walk at their usual pace for at least 10 minutes.
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
Each session (48) consist in isotonic exercises of low intensity and joint mobility of the lower extremities. These exercises are usually prescribed in medical consultations for the treatment of knee osteoarthritis.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
It is a self-questionnaire consisting of 24 items divided into 3 sub-scales: pain (5 items): when walking on level ground, using stairs, in bed, sitting or lying down, and standing. Rigidity (2 items) morning and during the rest of the day. Functional capacity (17 items): use of stairs, getting up from sitting, standing, stooping, walking, getting in / out of a car, going shopping, putting on / taking off socks and / or socks, getting out of bed, lying on the bed, entering / leaving the shower / tub, sitting and getting up from the toilet, performing heavy and light household chores.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Numeric pain Rating Scale (NRS)
Description
The NRS is a one-dimensional measure of pain intensity. The format is a line in which the participant selects a number between 0-10 that best reflects the intensity of the pain itself. A higher value corresponds to a greater intensity of pain.
Time Frame
16 weeks
Title
Timed 10-Meter Walk Test (10-MWT)
Description
It is a test for the evaluation of the usual and maximum gait speed along a distance of 10 meters corridor.
Time Frame
16 weeks
Title
6-Minute Walk Test (6-MWT)
Description
It is a test that evaluates the maximum distance a participant can walk during 6 minutes along a 30 meter long corridor.
Time Frame
16 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 60 years Knee pain Score in Kellgren-Lawrence Scale ≥1 Exclusion Criteria: Unable to ambulate independently Mini-mental state examination score < 24 Barthel Index score < 80 Unstable cardiovascular disease Neurological disorder that could compromise exercising Upper or lower-extremity fracture in the past year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JF Lisón, PhD
Organizational Affiliation
Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad CEU Cardenal Herrera
City
Moncada
State/Province
Valencia
ZIP/Postal Code
46113
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis

We'll reach out to this number within 24 hrs