NCT02543450

Brief Summary

In hemiplegic stroke patients, gait performance is affected by impaired walking endurance. Evidence has shown that higher exercise intensity improves cardiovascular fitness, while greater dose in task repetition benefits locomotor function. Therefore, the goal of this study is to examine the effect of a combined cardiovascular/task-oriented interval training programme on the walking capacity of chronic stroke individuals and the improvement in their participation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

September 3, 2015

Last Update Submit

August 27, 2020

Conditions

Keywords

Chronic strokeParticipationWalking ability

Outcome Measures

Primary Outcomes (1)

  • Participation (Frenchay Activities Index (FAI))

    Frenchay Activities Index (FAI)

    At 3 months

Secondary Outcomes (2)

  • Walking ability

    At 3 months

  • Upper limb function (Fugl-Meyer Assessment)

    At 3 months

Study Arms (2)

Cardiovascular/task-oriented training

EXPERIMENTAL

8 cardiovascular exercises at moderate intensity, interrupted by 1-minute active breaks of task-oriented exercises.

Other: Cardiovascular and task-oriented training

Upper limb strength training program

ACTIVE COMPARATOR

Nine 5-minute station circuit session. Patients work 2+2 minutes in each exercise, with a 30-second rest between the 2-minute periods and between stations.

Other: Upper limb strength training program

Interventions

Cardiovascular/task-oriented training
Upper limb strength training program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than 6 months after first stroke

You may not qualify if:

  • Functional disability not related to the aftermath of stroke
  • Participate in other rehabilitation programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

  • Sanchez-Sanchez ML, Ruescas-Nicolau MA, Perez-Miralles JA, Marques-Sule E, Espi-Lopez GV. Pilot randomized controlled trial to assess a physical therapy program on upper extremity function to counteract inactivity in chronic stroke. Top Stroke Rehabil. 2017 Apr;24(3):183-193. doi: 10.1080/10749357.2016.1245395. Epub 2016 Oct 19.

MeSH Terms

Conditions

Stroke

Interventions

Blood Circulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Sánchez-Sánchez ML

    University of Valencia

    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
Profesor

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 7, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 30, 2015

Last Updated

August 28, 2020

Record last verified: 2020-08

Locations