NCT04657029

Brief Summary

A single-blinded crossover study. Participants attended two separate sessions at the university campus, completing an aerobic exercise intervention in one session and a resting control condition in the other session. Sensorimotor adaptation was assessed before and after each session. Participants were twenty people with chronic stroke. Intervention completed was treadmill exercise at mod-high intensity for 30 minutes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
Last Updated

December 8, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

November 22, 2020

Last Update Submit

November 30, 2020

Conditions

Keywords

sensorimotor adaptationaerobic exercise

Outcome Measures

Primary Outcomes (1)

  • Sensorimotor adaptation change

    Participants were seated in front of a desk and asked to move a digitising pen on a digitizing tablet from an origin to a target point. The pen's position on the tablet (XY coordinates) was sampled at 100 Hz and displayed in real time as a circular cursor with a 5-pixel radius (1.25 mm) on a horizontally placed computer monitor. Direct vision of the hand was prevented by placing the tablet and the hand directly beneath an opaque stand, with the horizontal monitor placed atop the stand.

    Pre and Post intervention and Pre and Post Control. There was one week between the two conditions

Study Arms (2)

Treadmill condition

EXPERIMENTAL

The intervention condition consisted of a single session of moderate-high intensity aerobic exercise (65% of heart rate reserve) for 30 minutes walking on a standard treadmill. The single treadmill session included a progressive increase in intensity to reach the target heart rate (approx. 5 mins) as well as a cooling down period (approx. 5 mins). The warm-up and cool-down were included as part of the total 30 minutes of walking exercise. Target heart rates were calculated using the Karvonen method \[25\] with levels adjusted for those taking heart rate lowering medications (i.e. beta blockers), following methods previously published in post stroke populations \[26, 27\]. Participants were asked to self-rate their intensity of exercise every 10 minutes verbally using BORG's 6-20 scale rating of perceived exertion \[28\]. Participants were instructed to walk at a pace that resulted in a rating between 11 (fairly light) and 14 (somewhat hard) on the scale.

Behavioral: Treadmill

Control condition

OTHER

The control condition involved an equivalent time period (30 minutes) of seated resting where participants were provided with an education session about the impact and effects of stroke by the same research assistant.

Behavioral: Treadmill

Interventions

TreadmillBEHAVIORAL

30 minutes of moderate-high intensity treadmill training.

Control conditionTreadmill condition

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of stroke
  • Time of stroke greater than three months ago
  • Be able to walk with or without and aid for at least 10 metres
  • Understand three stage commands

You may not qualify if:

  • Unable to walk independently prior to current stroke
  • Have co-morbidities that limit their walking (e.g. arthritis, orthopaedic surgery)
  • Unstable cardiac status
  • Unable to understand three stage commands
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Queensland

Brisbane, Queensland, 4072, Australia

Location

Related Publications (1)

  • Neva JL, Ma JA, Orsholits D, Boisgontier MP, Boyd LA. The effects of acute exercise on visuomotor adaptation, learning, and inter-limb transfer. Exp Brain Res. 2019 Apr;237(4):1109-1127. doi: 10.1007/s00221-019-05491-5. Epub 2019 Feb 18.

    PMID: 30778618BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded Assessors
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: In a cross-over design, each participant was pseudo-randomised to complete an intervention condition (Treadmill) or control condition (Rest) first, returning at least one week later (washout period) to complete the alternate condition. A minimum washout period of one week was used to allow for any physiological changes due to exercise to return to resting levels, but to minimise any stroke recovery-associated changes to function. Participants were asked to refrain from exercising in the 24 hours prior to their visit. At each visit, participants completed the sensorimotor adaptation task on two occasions, pre and post intervention, resulting in four assessment timepoints (PreControl, PostControl and PreTreadmill, PostTreadmill). The post intervention assessment aimed to commence within 15 minutes of completing the treadmill or rest condition.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2020

First Posted

December 8, 2020

Study Start

June 1, 2017

Primary Completion

July 1, 2019

Study Completion

March 1, 2020

Last Updated

December 8, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations