Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee

• Registration Number: NCT03951506
• Lead Sponsor: Cardenal Herrera University

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.

Study Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-15
• Study Start: 2019-05-26
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	16 weeks	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

Name	Time	Method
Numeric pain Rating Scale (NRS)	16 weeks	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)	16 weeks	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)	16 weeks	It is a test that evaluates the maximum distance a participant can walk during 6 minutes along a 30 meter long corridor.

Trial Locations

Locations (1)

Universidad CEU Cardenal Herrera; 🇪🇸 Moncada, Valencia, Spain