NCT06292442

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

January 28, 2024

Last Update Submit

March 4, 2024

Conditions

Keywords

aerobic capacity, chronic stroke, high-intensity interval training, muscle atrophy, muscle strength, stroke

Outcome Measures

Primary Outcomes (4)

  • Muscle strength

    Manual Muscle Testing is a test that is used to assess muscle strength.

    4th week

  • Muscle Atrophy

    Measuring tape is used to measure the calf circumference to measure the atrophy, muscle size over time.

    4th week

  • 6-Minute Walk Test (6MWT)

    6-Minute Walk Test (6MWT) used to measure Functional capacity, aerobic fitness and endurance.

    4th week

  • Aerobic Capacity

    Harvard Step Test is used to measure Functional capacity, aerobic fitness and endurance.

    4th week

Secondary Outcomes (1)

  • Fastest Gait Speed

    4th week

Study Arms (2)

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.

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

Other: High intensity interval training

Interventions

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.

Traditional physical therapy

This group received High Intensity interval training along with conventional treatment for lower limb muscles, performed 3 times per week fr 4 weeks.

High intensity interval training

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 33809413BACKGROUND
  • 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: 34102144BACKGROUND
  • 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.

    PMID: 36623990BACKGROUND
  • 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.

    PMID: 36822187BACKGROUND
  • 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.

    PMID: 34271979BACKGROUND
  • 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.

    PMID: 35290104BACKGROUND
  • 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.

    PMID: 36865178BACKGROUND
  • 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.

    PMID: 32344098BACKGROUND
  • 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.

    PMID: 35185766BACKGROUND
  • 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.

    PMID: 35715374BACKGROUND

MeSH Terms

Conditions

StrokeMuscular Atrophy

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2024

First Posted

March 5, 2024

Study Start

September 1, 2023

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations