Clinical trial NCT06292442: Effects of HIIT on Muscle Strength, Atrophy and Aerobic Capacity in Stroke Patients.
Official title: Effects of High-Intensity Interval Training on Muscle Strength, Atrophy and Aerobic Capacity in Stroke Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: aerobic capacity, chronic stroke, high-intensity interval training, muscle atrophy, muscle strength, stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of High-Intensity Interval Training on muscle strength, atrophy, and aerobic capacity in stroke patients.


Eligibility criteria: Inclusion Criteria:

* Both males and females were included
* aged 40-60 years
* Chronic stroke patients who experienced a first-ever ischemic stroke
* Stable cardiovascular condition (American Heart Association class B)
* Physician clearance to participate in a 4-week HIIT program
* No prior structured exercise in the last 3 months
* Ability to walk 10 m over ground with or without assistive devices
* Patients who scored \>24/30 on MMSE (Mini-Mental State Examination)

Exclusion Criteria:

* Patients who were hospitalized for cardiac or pulmonary disease within the past 3 months
* Patients who had implanted pacemaker or defibrillator
* Patients having conditions where VO2peak assessment is contraindicated, such as uncontrolled hypertension(\>180/100), severe aortic stenosis, acute myocarditis, recent myocardial infarction, or other acute cardiovascular events within the past three months, were excluded from the study
* Patients with severe lower limb spasticity (Ashworth Scale scores \>2 of 4 for knee flexion, knee extension, or ankle dorsiflexion)
* Pregnant females
* Previous exposure to fast treadmill walking in the past year

Primary outcomes:
measure: Muscle strength
timeFrame: 4th week
measure: Muscle Atrophy
timeFrame: 4th week
measure: 6-Minute Walk Test (6MWT)
timeFrame: 4th week
measure: Aerobic Capacity
timeFrame: 4th week
Secondary outcomes:
measure: Fastest Gait Speed
timeFrame: 4th week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital, Lahore
state: Punjab
Study officials:
affiliation: Riphah international university lahore campus
name: Binash Afzal, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hugues N, Pellegrino C, Rivera C, Berton E, Pin-Barre C, Laurin J. Is High-Intensity Interval Training Suitable to Promote Neuroplasticity and Cognitive Functions after Stroke? Int J Mol Sci. 2021 Mar 16;22(6):3003. doi: 10.3390/ijms22063003.
citation: 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.
citation: Krawcyk RS, Vinther A, Petersen NC, Faber J, Iversen HK, Christensen T, Klausen TW, Kruuse C. High-intensity training in patients with lacunar stroke: A one-year follow-up. J Stroke Cerebrovasc Dis. 2023 Apr;32(4):106973. doi: 10.1016/j.jstrokecerebrovasdis.2022.106973. Epub 2023 Jan 7.
citation: Boyne P, Billinger SA, Reisman DS, Awosika OO, Buckley S, Burson J, Carl D, DeLange M, Doren S, Earnest M, Gerson M, Henry M, Horning A, Khoury JC, Kissela BM, Laughlin A, McCartney K, McQuaid T, Miller A, Moores A, Palmer JA, Sucharew H, Thompson ED, Wagner E, Ward J, Wasik EP, Whitaker AA, Wright H, Dunning K. Optimal Intensity and Duration of Walking Rehabilitation in Patients With Chronic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2023 Apr 1;80(4):342-351. doi: 10.1001/jamaneurol.2023.0033.
citation: Miller A, Reisman DS, Billinger SA, Dunning K, Doren S, Ward J, Wright H, Wagner E, Carl D, Gerson M, Awosika O, Khoury J, Kissela B, Boyne P. Moderate-intensity exercise versus high-intensity interval training to recover walking post-stroke: protocol for a randomized controlled trial. Trials. 2021 Jul 16;22(1):457. doi: 10.1186/s13063-021-05419-x.
citation: Anjos JM, Neto MG, Dos Santos FS, Almeida KO, Bocchi EA, Lima Bitar YS, Duraes AR. The impact Of high-intensity interval training On functioning And health-related quality Of life In post-stroke patients: A systematic review With meta-analysis. Clin Rehabil. 2022 Jun;36(6):726-739. doi: 10.1177/02692155221087082. Epub 2022 Mar 15.
citation: Boyne P, Miller A, Schwab SM, Sucharew H, Carl D, Billinger SA, Reisman DS. Training parameters and longitudinal adaptations that most strongly mediate walking capacity gains from high-intensity interval training post-stroke. medRxiv [Preprint]. 2023 Feb 23:2023.02.20.23286194. doi: 10.1101/2023.02.20.23286194.
citation: Hsu CC, Fu TC, Huang SC, Chen CP, Wang JS. Increased serum brain-derived neurotrophic factor with high-intensity interval training in stroke patients: A randomized controlled trial. Ann Phys Rehabil Med. 2021 Jul;64(4):101385. doi: 10.1016/j.rehab.2020.03.010. Epub 2020 May 11.
citation: Boyne P, Doren S, Scholl V, Staggs E, Whitesel D, Carl D, Shatz R, Sawyer R, Awosika OO, Reisman DS, Billinger SA, Kissela B, Vannest J, Dunning K. Preliminary Outcomes of Combined Treadmill and Overground High-Intensity Interval Training in Ambulatory Chronic Stroke. Front Neurol. 2022 Feb 4;13:812875. doi: 10.3389/fneur.2022.812875. eCollection 2022.
citation: Plummer P. Critically appraised paper: High-intensity interval training after stroke improves some aspects of physical function, but benefits are not sustained. J Physiother. 2022 Jul;68(3):204. doi: 10.1016/j.jphys.2022.05.014. Epub 2022 Jun 14. No abstract available.