Reactive Balance Training and Fitness

NCT04042961 | Terminated DMC

• 1 other identifier: 18-5784
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

People with stroke should exercise to maintain function and reduce the risk of another stroke. Different types of exercise target different components of fitness, such as aerobic, strength, and balance. Post-stroke exercise guidelines exist for each type of exercise separately (eg, brisk walking as aerobic exercise, resistance training for strength, and Tai Chi for balance). Meeting these recommendations means spending a lot of time exercising, and people with stroke say that lack of time and fatigue are barriers to exercise. It is possible to target several components of fitness with one type of exercise. 'Reactive balance training' (RBT) is a type of exercise that improves control of reactions that are needed to prevent a fall after losing balance, and is the only type of exercise with potential to prevent falls in daily life post-stroke. Because RBT involves repeated whole-body movements it may have similar aerobic benefit as other exercises using whole-body movements (eg, brisk walking). Also, leg muscles need to generate a lot of force to make rapid steps in RBT; repeatedly generating this force may help to improve strength. The purpose of this study is to determine if RBT improves two important components of fitness among people with chronic stroke: aerobic capacity and strength. The investigators expect that the improvements in aerobic capacity and strength after RBT will not be any worse than after an exercise program that specifically targets aerobic fitness and strength. A secondary purpose of this study is to determine the effects of RBT compared to aerobic and strength training on balance control and balance confidence. The investigators expect that RBT will lead to greater improvements in balance control and balance confidence than an aerobic and strength training program.

Conditions

CVA (Cerebrovascular Accident)

Outcome Measures

Primary Outcomes (2)

• Aerobic capacity

  A symptom-limited cardiopulmonary exercise test (CPET) will be performed. The CPET will be medically supervised. It will be conducted on the same modality on subsequent assessments and at the same time of day as the supervised exercise classes to minimize effects of heart rate altering medication on exercise prescription. Resistance will be increased every minute until either the patient indicates that he/she would like to stop or abnormalities appear that necessitate discontinuing the test. Breath-by-breath gas samples will be collected via calibrated metabolic cart to determine V̇O2peak and V̇O2VT.

  Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.

• Lower extremity strength

  Peak isokinetic torque will be measured using a isokinetic dynamometer. Participants will be seated in the chair (hips at approximately 90 degrees) with the axis of rotation of the dynamometer aligned to the femoral condyles. Shoulder straps will secure the torso and a thigh strap over the active leg will minimize compensatory movements during testing. The inactive leg will be positioned at 90 degrees knee flexion and held in place with a padded bar below the seat. Peak isokinetic muscle torque at a speed of 60 degrees/s will be assessed. Two to three warm-up contractions will be performed at \~50-75% of perceived maximum effort. This will be followed by 5 maximal efforts to obtain peak torque. A one-minute rest will be given between trials to minimize fatigue. The highest torque achieved among the three maximal trials will be used as the peak isokinetic torque. The task will be performed for both legs.

  Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.

Secondary Outcomes (7)

• Berg balance scale

  Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.

• Mini-Balance Evaluation Systems Test

  Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.

• Six-minute walk test

  Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.

• Activities-specific Balance Confidence scale

  Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.

• Falls in daily life

  For 12 months post-intervention

Study Arms (2)

Reactive balance training

EXPERIMENTAL

Other: Reactive balance training

Aerobic and strength training

ACTIVE COMPARATOR

Other: Aerobic and strength training (AST)

Interventions

Reactive balance training OTHER

A variety of tasks will be included to induce external or internal perturbations. External perturbations will be caused by forces outside participants' control (e.g. a push or pull from the physiotherapist). Internal perturbations are when the participant fails to control the centre of mass-base of support relationship during voluntary movement; e.g., 'agility' tasks such as kicking a soccer ball. Each session will include a five-minute warm-up, at least 60 perturbations, and a five-minute cool-down. The difficulty of the task will be set such that participants will 'fail' to recover balance \~50% of the time; 'failure' is defined as use of an upper extremity response, use of external assistance (i.e. from the overhead harness or physiotherapist), or taking more than 2 steps to regain stability. Training tasks will progressed by increasing the perturbation magnitude, including cognitive or movement tasks, or imposing sensory or environmental challenges (e.g. eyes closed, obstacles).

Reactive balance training

Aerobic and strength training (AST) OTHER

AST sessions will consist of 30 minutes of aerobic and 30 minutes of strength training. Aerobic training: Aerobic training will be done using treadmill walking or combination of modalities (e.g. cycling or recumbent stepping) for those unable to maintain the target heart rate with walking. The heart rate that occurred at the ventilatory threshold (V̇O2VT) during the cardiopulmonary exercise test will be used to prescribe intensity. In the absence of a discernible V̇O2VT a combination of the following will be used: 60-80% of heart rate reserve, peak oxygen uptake, and rating of perceived exertion of 11-16 (Borg 6-20 scale). Prescriptions will be initially progressed by increasing duration to ≥20 minutes and then increasing intensity to target heart rate. Resistance training: Participants will be prescribed 1-2 sets of 8 exercises per session (squat, heel raise, ankle dorsiflexion, knee extension and flexion, abdominal curl-up, wall push up, bicep curl), at 70% of 1 repetition maximum.

Aerobic and strength training

Eligibility Criteria

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

You may qualify if:

• Community-dwelling adults with chronic stroke (\>6 months post-stroke).
• Able to stand independently without upper-limb support for \>30 seconds.
• Able to tolerate at least 10 postural perturbations while wearing a safety harness.

You may not qualify if:

• \>2.1m tall and/or weighing \>150kg (limits of the safety harness system).
• Other neurological condition that could affect balance control (e.g., Parkinson's disease).
• Lower extremity amputation.
• Cognitive, language or communication impairments affecting understanding instructions.
• Recent (last 6 months) significant illness, injury or surgery.
• Severe osteoporosis, defined by diagnosis of osteoporosis with fracture.
• Severe uncontrolled hypertension, or uncontrolled diabetes.
• Contraindications to exercise testing, such as symptomatic aortic stenosis, complex life-threatening arrhythmias, unstable angina, or orthostatic blood pressure decrease of \>20 mmHg with symptoms.
• Acute or chronic illness or injury likely to be exacerbated by exercise (e.g., recent lower-extremity fracture).
• Currently attending in- or out-patient physiotherapy, in which they receive aerobic training, balance training or strength training for lower limb.
• Significant exercise participation: current physical activity levels that meet the recommended guidelines (at least 150 minutes of moderate-to-vigorous or at least 75 minutes of vigorous physical activity/week) as calculated using the moderate and vigorous components of the Leisure Time Exercise Questionnaire (LTEQ) in the month prior to starting the study.
• Received perturbation training at Toronto Rehab \<1 year previously.

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• University of Toronto: collaborator
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

Location

Related Publications (5)

• Mansfield A, Aqui A, Danells CJ, Knorr S, Centen A, DePaul VG, Schinkel-Ivy A, Brooks D, Inness EL, Mochizuki G. Does perturbation-based balance training prevent falls among individuals with chronic stroke? A randomised controlled trial. BMJ Open. 2018 Aug 17;8(8):e021510. doi: 10.1136/bmjopen-2018-021510.

  PMID: 30121600 BACKGROUND

• Marzolini S, Brooks D, Oh P, Jagroop D, MacIntosh BJ, Anderson ND, Alter D, Corbett D. Aerobic With Resistance Training or Aerobic Training Alone Poststroke: A Secondary Analysis From a Randomized Clinical Trial. Neurorehabil Neural Repair. 2018 Mar;32(3):209-222. doi: 10.1177/1545968318765692. Epub 2018 Mar 30.

  PMID: 29600726 BACKGROUND

• Boyne P, Reisman D, Brian M, Barney B, Franke A, Carl D, Khoury J, Dunning K. Ventilatory threshold may be a more specific measure of aerobic capacity than peak oxygen consumption rate in persons with stroke. Top Stroke Rehabil. 2017 Mar;24(2):149-157. doi: 10.1080/10749357.2016.1209831. Epub 2016 Jul 25.

  PMID: 27454553 BACKGROUND

• Flansbjer UB, Holmback AM, Downham D, Lexell J. What change in isokinetic knee muscle strength can be detected in men and women with hemiparesis after stroke? Clin Rehabil. 2005 Aug;19(5):514-22. doi: 10.1191/0269215505cr854oa.

  PMID: 16119407 BACKGROUND

• Barzideh A, Marzolini S, Danells C, Jagroop D, Huntley AH, Inness EL, Mathur S, Mochizuki G, Oh P, Mansfield A. Effect of reactive balance training on physical fitness poststroke: study protocol for a randomised non-inferiority trial. BMJ Open. 2020 Jun 30;10(6):e035740. doi: 10.1136/bmjopen-2019-035740.

  PMID: 32606059 DERIVED

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

• Avril Mansfield, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 2, 2019
• Study Start: September 1, 2019
• Primary Completion: May 28, 2024
• Study Completion: May 16, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)