Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis

NCT03951506 | Completed DMC

• 1 other identifier: UNIVERSITY CARDENAL HERRERA-20
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Numeric pain Rating Scale (NRS)

  16 weeks

• Timed 10-Meter Walk Test (10-MWT)

  16 weeks

• 6-Minute Walk Test (6-MWT)

  16 weeks

Study Arms (2)

Experimental-Multi-modal exercise program

EXPERIMENTAL

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.

Other: Multi-modal exercise program

Experimental-conventional treatment

EXPERIMENTAL

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.

Other: Conventional treatment

Interventions

Multi-modal exercise program OTHER

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.

Experimental-Multi-modal exercise program

Conventional treatment OTHER

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-conventional treatment

Eligibility Criteria

• Age: 60 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

Location

Study Officials

• JF Lisón, PhD

  Cardenal Herrera University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medicine

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 15, 2019
• Study Start: May 26, 2019
• Primary Completion: October 15, 2019
• Study Completion: October 30, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

ES (1)