Clinical trial NCT04623060: Low-Volume Interval Training and Resistance Exercise in Individual With Stroke
Official title: Feasibility of Low-Volume Interval Training and Resistance Exercise on Walking Performance, Aerobic Fitness, Muscle Strength and Quality Of Life in Individual With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Low-Volume Interval Training
Resistance Training
Lead sponsor: Universiti Teknologi Mara
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* Aphasia
* 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.

Primary outcomes:
measure: Change in Six Minute Walk Test
timeFrame: 0, 6 weeks
Secondary outcomes:
measure: Change in 10-meter walk test
timeFrame: 0, 6 weeks
measure: Change in Lower Limb Muscle Strength
timeFrame: 0, 6 weeks
measure: Change in Timed Up and Go test
timeFrame: 0, 6 weeks
measure: Stroke Impact Scale (SIS)
timeFrame: 0,week 6
measure: Adherence
timeFrame: 0 to 6 weeks
measure: Adverse Events
timeFrame: 0 to 6 weeks
measure: Patient satisfaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
state: Selangor
Study officials:
affiliation: Universiti Teknologi Mara
name: Mohd Haidzir Abd Manaf, PhD
role: PRINCIPAL_INVESTIGATOR
References: