StrokeNCT06292442
Effects of HIIT on Muscle Strength, Atrophy and Aerobic Capacity in Stroke Patients.
A study testing traditional physical therapy and High intensity interval training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of High-Intensity Interval Training on muscle strength, atrophy, and aerobic capacity in stroke patients. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- traditional physical therapy and High intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High-Intensity Interval Training on Muscle Strength, Atrophy and Aerobic Capacity in Stroke Patients.
To determine the effects of High-Intensity Interval Training on muscle strength, atrophy, and aerobic capacity in stroke patients.
- Conditions
- Stroke
- Being tested
- traditional physical therapy, High intensity interval training
- Keywords
- aerobic capacity, chronic stroke, high-intensity interval training, muscle atrophy, muscle strength, stroke
- Medical subject headings
- Stroke, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional physical therapyOther
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 trainingOther
This group received High Intensity interval training along with conventional treatment for lower limb muscles, performed 3 times per week fr 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Traditional physical therapy | Active comparator | 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. Receives: Other: traditional physical therapy |
| High intensity interval training | Experimental | This group received high-intensity interval training along with conventional treatment for the lower limb muscles Receives: Other: High intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Manual Muscle Testing is a test that is used to assess muscle strength.
Measured: 4th week
Muscle Atrophy
Measuring tape is used to measure the calf circumference to measure the atrophy, muscle size over time.
Measured: 4th week
6-Minute Walk Test (6MWT)
6-Minute Walk Test (6MWT) used to measure Functional capacity, aerobic fitness and endurance.
Measured: 4th week
Aerobic Capacity
Harvard Step Test is used to measure Functional capacity, aerobic fitness and endurance.
Measured: 4th week
Secondary outcomes (1)
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.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Sep 2023
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, PHD*, Principal investigator, Riphah international university lahore campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292442
- Sponsor's protocol ID
- REC/RCR&AHS/23/0237
- Status last verified
- Mar 2024
- First submitted
- 28 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33809413Gjellesvik 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.
PubMed 34102144Krawcyk 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.
PubMed 36623990Boyne 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.
PubMed 36822187Miller 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.
PubMed 34271979Anjos 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.
PubMed 35290104Boyne 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.
PubMed 36865178Hsu 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.
PubMed 32344098Boyne 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.
PubMed 35185766Plummer 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.
PubMed 35715374
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Interval Training on Muscle Strength, Atrophy and Aerobic Capacity in Stroke Patients.
- ClinicalTrials.gov ID
- NCT06292442
- Acronym / sponsor ID
- REC/RCR&AHS/23/0237
- Conditions
- Stroke
- Keywords
- aerobic capacity, chronic stroke, high-intensity interval training, muscle atrophy, muscle strength, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effects of High-Intensity Interval Training on muscle strength, atrophy, and aerobic capacity in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional physical therapy | Active comparator | Other: traditional physical therapyThis 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 | Experimental | Other: High intensity interval trainingThis group received high-intensity interval training along with conventional treatment for the lower limb muscles |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional physical therapyThis 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. | Other | Traditional physical therapy |
| High intensity interval trainingThis group received High Intensity interval training along with conventional treatment for lower limb muscles, performed 3 times per week fr 4 weeks. | Other | High intensity interval training |
Primary outcome
Muscle strength
Time frame: 4th week
Manual Muscle Testing is a test that is used to assess muscle strength.
Muscle Atrophy
Time frame: 4th week
Measuring tape is used to measure the calf circumference to measure the atrophy, muscle size over time.
6-Minute Walk Test (6MWT)
Time frame: 4th week
6-Minute Walk Test (6MWT) used to measure Functional capacity, aerobic fitness and endurance.
Aerobic Capacity
Time frame: 4th week
Harvard Step Test is used to measure Functional capacity, aerobic fitness and endurance.
1 secondary outcome
Fastest Gait Speed
Time frame: 4th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 33809413Hugues 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.
- Background: PubMed 34102144Gjellesvik 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.
- Background: PubMed 36623990Krawcyk 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.
- Background: PubMed 36822187Boyne 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.
- Background: PubMed 34271979Miller 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.
- Background: PubMed 35290104Anjos 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.
- Background: PubMed 36865178Boyne 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.
- Background: PubMed 32344098Hsu 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.
- Background: PubMed 35185766Boyne 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.
- Background: PubMed 35715374Plummer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binash Afzal, PHD* principal investigator
Riphah international university lahore campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional physical therapy and High intensity interval training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: 4th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06292442, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.