NCT02923765

Stepper Aerobic Training on Fitness, Disability, Inflammation and Thrombosis in Stroke Patients

Completed NA Last updated 29 July 2021

What this trial tests

NA trial testing Aerobic training by a stepper in Ischemic Stroke in 44 participants. Completed in 30 September 2020.

Timeline

1 August 2017

Primary endpoint
26 February 2020

30 September 2020

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	1 August 2017
Primary completion	26 February 2020
Estimated completion	30 September 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• Aerobic training by a stepper

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

Chang Gung Memorial Hospital

Who can join

20 and older, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stroke rehabilitation of hemiplegics primarily lies in motor control and training of activities of daily life. Whole body aerobics is much less emphasized. Nonetheless, cardiopulmonary fitness of even ambulatory hemiparetics is only half compared with healthy people, which is prone to deconditioning. The present study aims to understand the efficacy of aerobic training in addition to the usual neuro-rehabilitation, including aerobic fitness, daily activities dependency, anti-inflammation and anti-thrombosis. This is a prospective and randomized design. The subjects will be recruited from the hospitalized patients in the rehabilitation ward of Chang Gung Memorial Hospital at Linkuo. 120 hemiplegic patients due to stroke will be enrolled and randomized into two groups: combined training (CT) and usual rehabilitation. Participants in CT will receive aerobics at moderate intensity in addition to the usual rehabilitation. The program has 35 minutes/session, 5 sessions/week and 4-5 weeks in total. A constant-power semi-recumbent stepper will be employed as the training modality. It uses bilateral reciprocal movement of the arm coupled with the opposite leg, which allows for a push and pull motion. Additional 20 healthy participants will also be recruited as the healthy control. Assessment before and after training includes: (I) graded cardiopulmonary exercise test using constant-load stepper. (II) Functional Independence Measure. (III) coagulation system assessment, using Thrombin generation assay and Ceveron alpha (Technoclone GmbH, Vienna, Austria) : Von Willebrand factor, tissue plasminogen activator, plasminogen activator inhibitor-1, D-dimer, factor VIII, etc. \[the 1st year\]; (IV) monocyte-platelet aggregation and its subtypes, using flow cytometry \[the 2nd year\]. ( V) systemic inflammation, platelet activation and prognostic biomarker：C-reactive protein, soluble P-selectin, asymmetric dimethylarginine, Lipoprotein-Associated Phospholipase A2, etc \[the 3rd year\]. Statistical analysis will use ANOVA with post-hoc, two-way repeated measure ANOVA, etc. The investigation will start after approval and end in 2019, July. We hope this investigation will establish a more comprehensive rehabilitation program for clinical application.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Physical fitness training for stroke patients.
   Saunders DH, Sanderson M, Hayes S, Johnson L, et al · · 2020 · cited 169× · PMID 32196635 · DOI 10.1002/14651858.cd003316.pub7