Effects of High Intensity Interval Training Versus Intermittent Functional Training on Cardiovascular Fitness, Physical Function and Cognition in Stroke.

Официальное название

Effects of High Intensity Interval Training Versus Intermittent Functional Training on Cardiovascular Fitness, Physical Function and Cognition in Stroke

Обзор

The aim of this study is to determine comparative effects of High intensity interval training versus Intermittent functional training on cardiovascular fitness, physical function and cognition in stroke.

Подробное описание

This randomized clinical trial will be conducted at General Hospital Lahore over the duration of ten months enrolling six months post stroke survivors. The 52 patients will be recruited through non-probability convenience sampling technique and will be randomly assigned to either the HIIT or IFT group through online randomizer tool. Both groups will undergo a 12-week intervention, consisting of three sessions per week with alternate-day training. The HIIT group will perform three sessions per week 30 minutes in total with each session consisting of 5 min intervals at 85-95% of their maximum heart rate, with 3-minute active recovery periods, while IFT group will perform three sessions per week 30 minutes in total with each session consisting of 6-9 circuits of task-oriented exercises both including a 5-min warm-up and cool down period. Data will be collected through different assessment tools including NIHSS (The National Institutes of Health Stroke Scale) to assess the severity of stroke, 6-minute walk test (6MWT) for cardiovascular fitness, MoCA (Montreal Cognitive Assessment or The MoCA Test) for cognition and Berg-balance scale (BBS) and TUG (Time Up and Go Test) for mobility and physical function

Вмешательства

• Другое Group A: High-Intensity Interval Training (HIIT)
  The intervention consists of HIIT protocol performed 3-5 days per week for a period of 12 weeks, focusing on either the fastest safe walking speed for mobility gains or maintaining 85%-95% of heart rate reserve or power output at 90%-100% VO2 peak. Each session should last 25-30 minutes, utilizing a burst-to-recovery ratio of 30 seconds of intense activity followed by 30-60 seconds to 3 minutes of recovery. Treadmills or recumbent steppers will be used, with careful monitoring of intensity to pr
• Другое Group B: Intermittent Functional Training (IFT)
  IFT exercises will be performed for 3-5 days per week sessions involve 6-9 circuits of task-oriented exercises lasting about 3 minutes each, designed to enhance functional ability. Each circuit combines more demanding tasks with less intense ones to maintain heart rates 30-50 beats per minute above resting levels, achieving moderate aerobic intensity for chronic stroke survivors. Exercises are tailored to individual needs and progressively increased in difficulty, including movements like rollin

Первичные конечные точки

• National Institutes of Health Stroke Scale(NIHSS) [Срок оценки: 12 weeks]
• MoCA (Montreal Cognitive Assessment ) [Срок оценки: 12 week]
• The 6-minute walk test (6MWT) for cardiorespiratory fitness [Срок оценки: 12 week]
• The Timed Up and Go (TUG) test for physical function and mobility [Срок оценки: 12 week]

Критерии участия

Inclusion Criteria:• Age 50-75 years

• Both male and female stroke patients are included.
• Unilateral stroke experienced greater than 6 months prior to enrollment
• NIHSS: National Institute of Health Stroke Scale (a score of 5 to 15 represents a moderate stroke)
• Able to walk 10 minutes over ground with assistive devices as needed without physical assistance
• Able to walk 3 minutes on the treadmill at greater than 0.3 mph with no aerobic exercise contraindications.
• Stable cardiovascular condition (American Heart Association class B)
• Not currently participating in formal rehabilitation.

Exclusion Criteria:• Significant resting ECG abnormalities

• Diagnosed cardiovascular abnormalities
• Evidence of myocardial ischemia or significant arrhythmia on stress test hospitalization for cardiac or pulmonary disease within the previous 3 months, pacemaker or implanted defibrillator
• Lower extremity (LE) claudication
• Unable to communicate with investigators or correctly answer consent comprehension questions
• Severe LE spasticity (Ashworth scale score >2)
• LE weight-bearing pain >4/10 on a visual analog scale.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 2 центра

• Riphah International University — Daska Kalan
• Riphah International University — Daska Kalan

Публикации

• Fulk GD, Echternach JL, Nof L, O'Sullivan S. Clinometric properties of the six-minute walk test in individuals undergoing rehabilitation poststroke. Physiother Theory Pract. 2008 May-Jun;24(3):195-204. doi: 10.1080/09593980701588284. PMID 18569856
• Nindorera F, Nduwimana I, Sinzakaraye A, Havyarimana E, Bleyenheuft Y, Thonnard JL, Kossi O. Effect of mixed and collective physical activity in chronic stroke rehabilitation: A randomized cross-over trial in low-income settings. Ann Phys Rehabil Med. 2023 May;66(4):101704. doi: 10.1016/j.rehab.2022.101704. Epub 2022 Dec 2. PMID 36115574
• Maeneja R, Silva CR, Ferreira IS, Abreu AM. Aerobic physical exercise versus dual-task cognitive walking in cognitive rehabilitation of people with stroke: a randomized clinical trial. Front Psychol. 2023 Oct 13;14:1258262. doi: 10.3389/fpsyg.2023.1258262. eCollection 2023. PMID 37901076
• Montero-Almagro G, Bernal-Utrera C, Geribaldi-Doldan N, Nunez-Abades P, Castro C, Rodriguez-Blanco C. Influence of High-Intensity Interval Training on Neuroplasticity Markers in Post-Stroke Patients: Systematic Review. J Clin Med. 2024 Mar 29;13(7):1985. doi: 10.3390/jcm13071985. PMID 38610750
• Gjellesvik TI, Becker F, Tjonna AE, Indredavik B, Lundgaard E, Solbakken H, Brurok B, Torhaug T, Lydersen S, Askim T. Effects of High-Intensity Interval Training After Stroke (The HIIT Stroke Study) on Physical and Cognitive Function: A Multicenter Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Sep;102(9):1683-1691. doi: 10.1016/j.apmr.2021.05.008. Epub 2021 Jun 6. PMID 34102144

Идентификаторы

NCT: NCT07274748 · REC/0271 Shamama Naqvi

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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