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CompletedNCT03951506MME-KOAUpdated Dec 11, 2019

Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis

An interventional study of Multi-modal exercise program and Conventional treatment in Osteo Arthritis Knee, sponsored by Cardenal Herrera University. Completed at 1 site in Spain. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-12-11.

Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Osteo Arthritis Knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 66 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Cardenal Herrera University is the lead sponsor of 104 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Experimental-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.

    Other: Multi-modal exercise program

  • Experimental
    Experimental-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.

    Other: Conventional treatment

Interventions

  • OtherMulti-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.

  • OtherConventional 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.

06

What researchers measure

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.

    Time frame: 16 weeks

Secondary outcomes

  1. 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.

    Time frame: 16 weeks

  2. 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.

    Time frame: 16 weeks

  3. 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.

    Time frame: 16 weeks

07

Study locations

1 site
  • Universidad CEU Cardenal Herrera
    Moncada, Valencia 46113, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03951506
Lead sponsor
Cardenal Herrera University
Responsible party
Juan F. Lisón Párraga, Dr (Head of Medicine, Cardenal Herrera University) — Principal investigator
First posted
May 15, 2019
Start date
May 26, 2019
Primary completion
Oct 15, 2019
Completion
Oct 30, 2019
Last update
Dec 11, 2019

Study contacts

JF Lisón, PhD
principal investigator · Cardenal Herrera University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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