Low-Volume Interval Training and Resistance Exercise in Individual With Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04623060
• Other study ID #: REC/401/19
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2020
• Source: Universiti Teknologi Mara
• Contact: Nur Ainna Adanan, BSc
• Phone: 60129471427
• Email: ainnaadanan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Combination of Low-volume interval treadmill training and Resistance Training
Low-volume interval training (LV-ITT) protocols included a 5 min warm-up (30%-50%VO2peak) up to 20min of LV-ITT and a 5 min cooling down (30%-50% VO2peak). The LV-ITT will repeat 60s bursts of fast treadmill walking at maximum tolerate speed (0% incline), alternate with pre-specified recovery periods about 4 minutes according to protocol. Each time the participants completed a burst successfully, treadmill speed will be increased by 0.1 mph for the next burst. The recovery periods will be 4 minutes. The intervention will be conducted for about 30 minutes. Resistance training will be conducted by using a horizontal leg press machine. They are encouraged to focus on an explosive concentric movement and a controlled eccentric movement such that the time on each phase was in the ratio 1:2.

Locations

Country	Name	City	State
Malaysia	Hospital Selayang	Batu Caves	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Teknologi Mara

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Six Minute Walk Test	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.	0, 6 weeks
Secondary	Change in 10-meter walk test	This assessment will include four 10-meter walking tasks at maximal comfortable speed.	0, 6 weeks
Secondary	Change in Lower Limb Muscle Strength	Handheld dynamometer for knee extensor	0, 6 weeks
Secondary	Change in Timed Up and Go test	Functional Balance	0, 6 weeks
Secondary	Stroke Impact Scale (SIS)	Quality of Life	0,week 6
Secondary	Adherence	Attendance and completion of home-based sessions measured via exercise diary	0 to 6 weeks
Secondary	Adverse Events	Any adverse event or near miss is required to be reported as standard of care at Selayang Hospital	0 to 6 weeks
Secondary	Patient satisfaction	Questionnaire	6 weeks