- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07649863
The Effect of Physical Activity on Knee Osteoarthritis, Pain and Gait
The Effect of Retro Walking on Pain and Gait Biomechanics Using Non-linear Analysis in People With Knee Osteoarthritis
Knee osteoarthritis, a chronic musculoskeletal disease, is the most prevalent type of osteoarthritis and the leading cause of disability and major healthcare costs worldwide. The pathogenesis of the disease is not fully understood and there are few non-invasive disease-modifying therapies available to patients. Therefore, there is a critical need to enhance therapeutic interventions, which requires improvement of our understanding of knee osteoarthritis pathogenesis.
Increasing evidence suggests that physical activity and exercise training are cost-effective and widely available interventions for the treatment of knee osteoarthritis, however, consideration of type of physical activity and optimal exercise modality are needed to reduce pain, improve gait, knee joint function, stiffness, and muscle weakness in individuals with knee osteoarthritis.
The aim of this pilot clinical trial is to compare individuals with knee osteoarthritis who have not exercised with individuals that have performed retro walking exercise chosen from the systematic review and survey we have conducted previously to reduce pain and improve gait.
Non-linear analyses will be performed to determine the effects of exercise intervention on gait biomechanics and stability of movement in these patients. These findings may form a basis for recommendations of exercise/physical activity interventions for the benefits of patients with knee osteoarthritis including pain reduction, mobility improvement and gait modification.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hasmik J Samvelyan, PhD
- Telefonní číslo: +441245683738
- E-mail: jasmine.samvelyan@aru.ac.uk
Studijní záloha kontaktů
- Jméno: Nathan Bytheway, MEng
- E-mail: NB941@pgr.aru.ac.uk
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Male and female
- Any ethnicity
- Adults over 18 years old
- Meet the UK guidelines for physical activity supported by NICE (National Institute for Health and Care Excellence) and NHS (able to exercise if it is safe with regular breaks)
- Otherwise, adults with clinically diagnosed knee osteoarthritis according to NICE criteria or confirmed by a healthcare professional able and willing to participate and provide written informed consent
Exclusion Criteria:
- Any musculoskeletal injury
- Any conditions known to affects gait (e.g. Parkinson's disease or stroke)
- Any surgical intervention in the previous 12 months on lower limbs
- Surgical replacement of hip or knee joints
- BMI (body mass index) over 35
- Athletes or take part in significant recreational activity
- Takes any medication known to affect the gait and ability to walk
- Received an intra-articular injection in the last 3 months
- Have been told by medical professionals that they should not take part in any intensity exercise/physical activity
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Exercise
Participants in the intervention group will perform treadmill retro walking exercise 3 days/week for 6 weeks.
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Prior to the intervention participants will be made familiar with retro walking on the treadmill. The exercise will consist of a forward walking for 5min on the treadmill for warm-up followed by retro walking for 10min and a cool-down for 5min. Participants will be instructed to increase their retro walking time up to 30min if the pain sensation continuously was reduced (pain scores < 3 numerical rating scale). The comfortable speed of the retro walking will be determined by the participant under supervision of the researchers. No slopes or inclination will be used in this study for participant safety. In the warm-up and cool-down sessions participants will be asked to perform muscle stretch, ankle toe movements and heel raise exercises.
Ostatní jména:
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Žádný zásah: Control
Participants in the control group will maintain their existing level of activity.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Knee function and associated frequency and severity of pain
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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Participants' opinion about their own knee function and associated problems will be assessed through self-administered and validated questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS). KOOS questionnaire designed to collectively evaluate and measure five outcomes in individuals with knee osteoarthritis including: Pain: Frequency and severity of knee pain. Symptoms: Swelling, grinding, stiffness, and range of motion issues. Activities of Daily Living (ADL): Difficulty with physical tasks like stairs, rising from a seat, or getting in and out of a car. Sports and Recreation Function: The ability to perform higher-level physical activities, such as running, squatting, or playing sports. Quality of Life (QOL): Knee-related lifestyle limitations and personal awareness of the joint. |
Baseline or Day 1 and end of study at 6 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain intensity
Časové okno: Baseline or Day 1 up to 6 weeks
|
A standardised tool numeric pain rating scale (NPRS) will be used to measure a participants' pain intensity. It is an 11-point scale ranging from 0 to 10. 0: Represents "no pain" whereas 10: Represents the "worst imaginable pain". Participants can state their number verbally or circle it on a chart. |
Baseline or Day 1 up to 6 weeks
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The gait biomechanics - change from baseline in spatiotemporal parameter walking speed at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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Spatiotemporal parameter walking speed (velocity, meters/sec) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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The gait biomechanics - change from baseline in spatiotemporal parameter cadence at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
|
Spatiotemporal parameter cadence (steps/min) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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The gait biomechanics - change from baseline in spatiotemporal parameter stride/step length at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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Spatiotemporal parameter stride/step length (meters or cm) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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The gait biomechanics - change from baseline in spatiotemporal parameter swing/stance phases at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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Spatiotemporal parameter swing/stance phases (% of gait cycle) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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The gait biomechanics - change from baseline in spatiotemporal parameter double support time at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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Spatiotemporal parameter double support time (% of gait cycle) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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The gait biomechanics - change from baseline in kinetic parameter knee adduction moment (KAM) at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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Kinetic parameter knee adduction moment (KAM) (Newton meters Nm) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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The gait biomechanics - change from baseline in kinetic parameter knee flexion/extension moment at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
|
Kinetic parameter knee flexion/extension moment (Newton meters Nm) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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The gait biomechanics - change from baseline in kinetic parameter vertical ground reaction force (vGRF) at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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Kinetic parameter vertical ground reaction force (vGRF) (Newtons N) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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The gait biomechanics - change from baseline in kinetic parameter joint contact force (JCF) at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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Kinetic parameter joint contact force (JCF) (Newtons N) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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The gait biomechanics - change from baseline in kinematic parameter knee flexion angle at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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Kinematic parameter knee flexion angle (Degrees (°)) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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The gait biomechanics - change from baseline in kinematic parameter Range of Motion (ROM) at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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Kinematic parameter Range of Motion (ROM) (Degrees (°)) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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The gait biomechanics - change from baseline in kinematic parameter knee adduction/abduction at 6 weeks
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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Kinematic parameter knee adduction/abduction (Degrees (°)) will be assessed using VICON motion capture analysis system.
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Baseline or Day 1 and end of study at 6 weeks
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Gait stability
Časové okno: Baseline or Day 1 and end of study at 6 weeks
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The stability of walking will be measured using non-linear analysis including Lyapunov (1/s or s^(-1)) and Hurst Exponents.
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Baseline or Day 1 and end of study at 6 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 356992
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