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Clinical Trials/NCT04623060
NCT04623060
Unknown
Not Applicable

Feasibility of Low-Volume Interval Training and Resistance Exercise on Walking Performance, Aerobic Fitness, Muscle Strength and Quality Of Life in Individual With Stroke

Universiti Teknologi Mara1 site in 1 country30 target enrollmentNovember 1, 2020
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Universiti Teknologi Mara
Enrollment
30
Locations
1
Primary Endpoint
Change in Six Minute Walk Test
Last Updated
5 years ago

Overview

Brief Summary

To examine the feasibility of Low-Volume Interval Training (LV-ITT) and Resistance Exercise (RE) on walking performance (walking endurance, gait speed, functional balance), lower limb muscle strength and quality of life among individuals with post-stroke.

Detailed Description

Prescribing aerobic and resistance training in concurrence is proposed as an optimum strategy to target cardiovascular as well as musculoskeletal functions in individuals with post-stroke. Lower limb's resistance training alone in chronic stroke produces a large effect on muscle strength. However, it has shown uncertainty results on walking performance. Therefore, it is suggested that to prescribe mix training (treadmill training and strength training) in order to improve muscle strength, gait performance and quality of life in stroke survivors. Previous studies have shown the effect of mixed training on walking performance and endurance in other populations such as multiple sclerosis and coronary artery disease. However, there is a lack of study that conducted mixed training among chronic post-stroke. Therefore, the feasibility study on the effectiveness of combining LV-ITT and RE in post-stroke should be conducted.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
August 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohd Haidzir Abd Manaf

Associate Professor

Universiti Teknologi Mara

Eligibility Criteria

Inclusion Criteria

  • Age range between 45-65 years' old
  • At least 3-months post-stroke
  • Gait speed ≤1.0 m·s -¹ measured by the 10 m walk test.
  • Able to walk 10 m overground with assistive devices as needed and no physical assistance.
  • Able to walk for 3 min on the treadmill at ≥0.17 m·s -¹ (0.4 mph) with no aerobic exercise contraindications.
  • Modified Rankin Score (mRS) of \<4 at the screening
  • American Heart Association class B (2), allowing for aerobic capacity \<6 metabolic equivalent (MET)

Exclusion Criteria

  • Significant resting ECG abnormalities
  • Hospitalization for cardiac or pulmonary disease within 3 months
  • Using Pacemaker
  • Significant musculotendinous or bony restrictions of the affected limb, or any serious chronic disease independently causing disability or profound atrophy of the affected limb that will comprise further indications to participation significant.

Outcomes

Primary Outcomes

Change in Six Minute Walk Test

Time Frame: 0, 6 weeks

This test measures the distance that an individual can quickly walk in a period of 6 minutes on a flat surface. Participants will complete one trial with the gait aide prescribed to them. The distance will be recorded. Participants can stop and rest or discontinue to the test at any time.

Secondary Outcomes

  • Change in Timed Up and Go test(0, 6 weeks)
  • Patient satisfaction(6 weeks)
  • Change in 10-meter walk test(0, 6 weeks)
  • Change in Lower Limb Muscle Strength(0, 6 weeks)
  • Adherence(0 to 6 weeks)
  • Stroke Impact Scale (SIS)(0,week 6)
  • Adverse Events(0 to 6 weeks)

Study Sites (1)

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