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

NCT04623060 | Unknown DMC

• 1 other identifier: REC/401/19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Low-Volume Interval Training; Resistance Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in 10-meter walk test

  0, 6 weeks

• Change in Lower Limb Muscle Strength

  0, 6 weeks

• Change in Timed Up and Go test

  0, 6 weeks

• Stroke Impact Scale (SIS)

  0,week 6

• Adherence

  0 to 6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

3 sessions/week for 6 weeks

Other: Combination of Low-volume interval treadmill training and Resistance Training

Interventions

Combination of Low-volume interval treadmill training and Resistance Training OTHER

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.

Intervention

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Teknologi Mara: lead

Study Sites (1)

Hospital Selayang

Batu Caves, Selangor, 68100, Malaysia

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mohd Haidzir Abd Manaf, PhD

  Universiti Teknologi Mara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nur Ainna Adanan, BSc

CONTACT

60129471427; ainnaadanan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 10, 2020
• Study Start: November 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2021
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)