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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Combination of Low-volume interval treadmill training and Resistance Training
Sponsored by
Universiti Teknologi Mara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Low-Volume Interval Training, Resistance Training

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital SelayangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

3 sessions/week for 6 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2020
Last Updated
November 9, 2020
Sponsor
Universiti Teknologi Mara
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1. Study Identification

Unique Protocol Identification Number
NCT04623060
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Teknologi Mara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Low-Volume Interval Training, Resistance Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
3 sessions/week for 6 weeks
Intervention Type
Other
Intervention Name(s)
Combination of Low-volume interval treadmill training and Resistance Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Six Minute Walk Test
Description
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.
Time Frame
0, 6 weeks
Secondary Outcome Measure Information:
Title
Change in 10-meter walk test
Description
This assessment will include four 10-meter walking tasks at maximal comfortable speed.
Time Frame
0, 6 weeks
Title
Change in Lower Limb Muscle Strength
Description
Handheld dynamometer for knee extensor
Time Frame
0, 6 weeks
Title
Change in Timed Up and Go test
Description
Functional Balance
Time Frame
0, 6 weeks
Title
Stroke Impact Scale (SIS)
Description
Quality of Life
Time Frame
0,week 6
Title
Adherence
Description
Attendance and completion of home-based sessions measured via exercise diary
Time Frame
0 to 6 weeks
Title
Adverse Events
Description
Any adverse event or near miss is required to be reported as standard of care at Selayang Hospital
Time Frame
0 to 6 weeks
Title
Patient satisfaction
Description
Questionnaire
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nur Ainna Adanan, BSc
Phone
60129471427
Email
ainnaadanan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohd Haidzir Abd Manaf, PhD
Organizational Affiliation
Universiti Teknologi Mara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Selayang
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nur Ainna Adanan, BSc
Phone
60129471427
Email
ainnaadanan@gmail.com
First Name & Middle Initial & Last Name & Degree
Norliza Zainudin, MMED

12. IPD Sharing Statement

Plan to Share IPD
No

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

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