- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07733518
Eccentric vs Low-Load Blood Flow Restriction Training in Knee Osteoarthritis in Knee Osteoarthritis (the)
Comparison of Eccentric and Low-Load Blood Flow Restriction Training on Neuromuscular Adaptations in Knee Osteoarthritis
Přehled studie
Postavení
Podmínky
Detailní popis
Osteoarthritis (OA) is a chronic disease affecting the joint and its tissues, primarily leading to progressive damage to articular cartilage and, subsequently, to the subchondral bone and surrounding synovial structures. This chronic degenerative disease affects approximately one-third of adults, and its prevalence increasing with advancing age. The knee is one of the most common joints affected by the OA. Systematic reviews indicate a global prevalence of knee osteoarthritis (KOA) is 22.9% among individuals aged 40 and older, affecting an estimated 654.1 million people worldwide, with variations across countries and increasing with age.
Knee osteoarthritis (KOA) is a multi etiological, chronic disabling disease that affects the entire knee joint, which is the most common site of involvement in OA. KOA patients mostly suffer from progressive stiffness and knee pain. Gradually, they have some difficulties in performing daily activities, such as walking, squatting, and climbing and doing housework, as the disease progresses. Ultimately, pain and disability associated with the disease lead to a loss of functional independence and a profound reduction in quality-of- life. Impairments that are caused by KOA include knee pain, limited ROM of the knee, muscle weakness and knee instability.
The gastrocnemius muscle plays a crucial role in knee joint stability and ankle-knee biomechanics through its biarticular function, contributing to both knee flexion and ankle plantarflexion. During the stance phase of gait, the gastrocnemius co-activates with the tibialis anterior and quadriceps muscles, providing dynamic stability, reducing medial knee laxity, and assisting in forward propulsion.
The impaired neuromuscular recruitment of the gastrocnemius may result in reduced push-off strength, prolonged ground contact time, and diminished functional performance, ultimately contributing to functional limitations in patients with knee osteoarthritis. However, surface electromyography (sEMG) enables the assessment of gastrocnemius motor unit recruitment and fatigue characteristics, providing objective insight into neuromuscular adaptations before and after targeted interventions.
OA of the knee is characterized by changes in gait kinematics. In patients with knee OA, deficits in gastrocnemius strength and endurance can exacerbate difficulties in activities such as stair climbing, walking, and balance maintenance. Eccentric and low-load blood flow restriction (LL-BFR) training protocols have been proposed to optimize gastrocnemius activation, enhance muscle strength, and improve functional performance, offering clinically relevant rehabilitation strategies for enhancing lower limb function and reducing disability in knee osteoarthritis.
This study is to find the effects of eccentric and low-load blood flow restriction training on neuromuscular adaptations, muscle strength, functional performance, and disability in individuals affected by the knee OA.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: KINZA ANWAR, MS-OMPT
- Telefonní číslo: +92-3239735427
- E-mail: kinza.anwar@riphah.edu.pk
Studijní místa
-
-
Punjab Province
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Rawalpindi, Punjab Province, Pákistán, 46000
- Nábor
- Railway General Hospital, Rawalpindi
-
Kontakt:
- KINZA ANWAR, MS-OMPT
- Telefonní číslo: +92-3239735427
- E-mail: kinza.anwar@riphah.edu.pk
-
Kontakt:
- SEHRISH MALIK, MS-OMPT*
-
Dílčí vyšetřovatel:
- SEHRISH MALIK, MS-OMPT*
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age group 40-70
- Both genders male and female
- Clinical diagnosis of knee OA (Kellgren-Lawrence grade 1-3) of the most symptomatic knee.
- Pain stable enough to permit exercise on Numeric Pain Rating Scale 3/10.
- Participants must demonstrate a gastrocnemius muscle strength of grade ≥3 on the Manual Muscle Testing (MMT) scale (0-5), assessed using the standard standing heel-rise position.
- Participants must be able to ambulate independently and participate in supervised exercise.
Exclusion Criteria:
• Presence of a prosthetic knee in the affected limb.
- Inflammatory arthritis (e.g., rheumatoid arthritis) or active flare-up of OA.
- Cardiovascular disease contraindicating exercise (e.g., unstable angina, recent MI, uncontrolled hypertension ≥160/100 mmHg).
- Pulmonary disease that limits safe participation (e.g., severe COPD, recent exacerbation).
- History of deep vein thrombosis (DVT), peripheral vascular disease, or bleeding/clotting disorders.
- Current anticoagulant therapy that increases bleeding risk (unless cleared by physician).
- Any pathology causing significant muscle weakness (e.g., neuromuscular disorders, severe neuropathy).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Eccentric Training
Eccentric Gastrocnemius Strengthening Exercises
|
Eccentric Gastrocnemius Strengthening Exercises .1.
Eccentric Heel Drop 2. leg press calf lowering 3. Eccentric Stair Descent (Frequency: 3 sets 10 reps in session 1-2). 1. Eccentric Heel Drop 2. leg press calf lowering 3. Eccentric Stair Descent (Frequency: 5 sets 15 reps in session 3-4).
Total duration is 3 sessions per week for 4 consecutive weeks.
|
|
Experimentální: Low-Load Blood Flow Restriction Training
|
Low-load blood flow restriction training including 1-Low-intensity gastrocnemius strengthening with BFR cuff 2-Controlled exercise with intermittent vascular occlusion (inflated 50-70% for 4 weeks, 3 rep. 1. Eccentric Heel Drop 2. leg press calf lowering 3. Eccentric Stair Descent (Frequency: 3 sets 10 reps in session 1-2). 1. Eccentric Heel Drop 2. leg press calf lowering 3. Eccentric Stair Descent (Frequency: 5 sets 12 reps in session 3-4). Total duration is 3 sessions per week for 4 consecutive weeks. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Surface Electromyography
Časové okno: Baseline and 4th week
|
The Electromyography (EMG) is an objective assessment tool used to measure the electrical activity of muscles during contraction.
Motor unit recruitment will be analyzed through the amplitude of EMG signals (root mean square, RMS), reflecting the number and synchronization of active motor units during contraction.
Fatigue characteristics will be assessed using changes in EMG frequency parameters (mean or median frequency), indicating alterations in muscle fiber conduction velocity and fatigue onset that will be assessed pre and post sessions.
|
Baseline and 4th week
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Časové okno: 4 weeks
|
The WOMAC is a widely used, validated questionnaire assessing pain, stiffness, and physical function in patients with knee osteoarthritis.
It consists of 24 items divided into three subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items).
|
4 weeks
|
|
Timed Up and Go (TUG)
Časové okno: 4 weeks
|
The Timed Up and Go (TUG) test assesses mobility and fall risk by timing how quickly a person can stand up from a standard armchair, walk 3 meters (10 feet) at a normal pace, turn around, walk back, and sit down again.
Individuals can use their routine walking aids, but receive no physical help during the test; completing the maneuver in under 10 seconds indicates normal independence, whereas taking 30 seconds or longer points to an elevated risk of falling.
|
4 weeks
|
|
Heel Raise Endurance Test
Časové okno: 4 weeks
|
The Heel Raise Endurance Test measures the number of consecutive heel raises a participant can perform (or the time sustained) while standing, usually at a controlled pace until fatigue.
It assesses calf muscle endurance, ankle plantar-flexor strength, and functional lower-limb performance, relevant for gait and mobility assessment.
The duration for which the position is maintained is recorded.
|
4 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: KINZA ANWAR, MS-OMPT, Riphah International University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
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
Klíčová slova
Další relevantní podmínky MeSH
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