Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee
• Interventions: Other: Conventional treatment; Other: Multi-modal exercise program

• 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

Arm && Interventions

Group	Intervention	Description
Experimental-conventional treatment	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.
Experimental-Multi-modal exercise program	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.

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