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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06292442
Other study ID # REC/RCR&AHS/23/0237
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date November 1, 2023

Study information

Verified date March 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date November 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
traditional physical therapy
This group received conventional physical therapy treatment including Range of Motion (ROM) exercises for the affected hip, knee, and ankle joints, as well as stretching exercises for tight lower limb muscles, administered 3 times per week for 4 weeks, with each session lasting approximately 20-30 minutes.
High intensity interval training
This group received High Intensity interval training along with conventional treatment for lower limb muscles, performed 3 times per week fr 4 weeks.

Locations

Country Name City State
Pakistan Jinnah Hospital, Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle strength Manual Muscle Testing is a test that is used to assess muscle strength. 4th week
Primary Muscle Atrophy Measuring tape is used to measure the calf circumference to measure the atrophy, muscle size over time. 4th week
Primary 6-Minute Walk Test (6MWT) 6-Minute Walk Test (6MWT) used to measure Functional capacity, aerobic fitness and endurance. 4th week
Primary Aerobic Capacity Harvard Step Test is used to measure Functional capacity, aerobic fitness and endurance. 4th week
Secondary Fastest Gait Speed 10-Meter Walk Test is a test used for assessing gait speed, monitoring rehabilitation progress, functional assessment, fall risk assessment, and research purposes. 4th week
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