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Completed

NCT Number: NCT03951506

Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis

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

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Key information

Conditions

Osteo Arthritis Knee

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 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 outcomes

  1. Numeric pain Rating Scale (NRS)

    Time frame: 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.

  2. Timed 10-Meter Walk Test (10-MWT)

    Time frame: 16 weeks

    It is a test for the evaluation of the usual and maximum gait speed along a distance of 10 meters corridor.

  3. 6-Minute Walk Test (6-MWT)

    Time frame: 16 weeks

    It is a test that evaluates the maximum distance a participant can walk during 6 minutes along a 30 meter long corridor.

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

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

Acronym: MME-KOA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 15, 2019
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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