Aerobic Exercise in Early Subacute Stroke

Stroke Clinical Trial

Official title:

Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107768
• Other study ID #: 2010/396-31
• Status: Completed
• Phase: N/A
• First received: April 3, 2014
• Last updated: February 3, 2015
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: February 2015
• Source: Ostergotland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to investigate the effects of early intensive aerobic exercise regarding aerobic capacity, gait and balance, Health Related Quality of Life and participation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Ability to understand Swedish language.

• Ability to walk 5 meters with or without the support of any means or person.

• Be able to get up on a cycle ergometer and cycle in their own chosen pace.

• Approval of medically responsible physician to conduct physical training in groups.

Exclusion Criteria:

• Medical or neurological diseases that may affect the exercise execution.

• Patients for whom transportation to and from hospital can not be arranged during intervention period

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Aerobic exercise
Other: Aerobic exercise The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added.The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20,Rate of Perceived Exertion (Borg 's RPE scale) . Two fitness goals was to be achieved during the training session 1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate. 2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) . Which corresponds to 85 % of maximum heart rate.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Klas Sandberg

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EQ5-D	Quality of life	Baseline,3month,6month	Yes
Other	Stroke Impact Scale	Recovery after stroke, participation	Baseline,3month,6month	Yes
Primary	Aerobic capacity	cardiorespiratory stress test (Watt)	Baseline,3month	Yes
Secondary	Balance	Time Up and Go(TUG) ,Single Leg Stance(SLS)	Baseline,3month	Yes
Secondary	Walking capacity	Six minute walk test (6MWT ), 10 meters Walking test	Baseline,3month	Yes