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

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: Combination of Low-volume interval treadmill training and Resistance Training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nur Ainna Adanan, BSc; Phone Number: 60129471427; Email: ainnaadanan@gmail.com

Study Locations

• Malaysia
  • Selangor
    • Batu Caves, Selangor, Malaysia, 68100
      • Recruiting
      • Hospital Selayang
      • Contact: Nur Ainna Adanan, BSc; Phone Number: 60129471427; Email: ainnaadanan@gmail.com
      • Sub-Investigator: Norliza Zainudin, MMED

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 3 sessions/week for 6 weeks

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universiti Teknologi Mara
• Investigators: Principal Investigator: Mohd Haidzir Abd Manaf, PhD, Universiti Teknologi Mara

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Resistance Training; Low-Volume Interval Training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: REC/401/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No