Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis

Osteo Arthritis Knee Clinical Trial

— MME-KOA  

Official title:

Effects a Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951506
• Other study ID #: UNIVERSITY CARDENAL HERRERA-20
• Status: Completed
• Phase: N/A
• Start date: May 26, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: December 2019
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: To evaluate the short-term effects of a multi-modal exercise program on physical performance variables in older adults with knee osteoarthritis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 30, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Multi-modal exercise program
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.
• Conventional treatment
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.

Locations

Country	Name	City	State
Spain	Universidad CEU Cardenal Herrera	Moncada	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks