Trial Outcomes & Findings for Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach (NCT NCT01161329)

Results Overview

Total score on the scale: 0-56 Points. Higher scores indicates better balance.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

67 participants

Primary outcome timeframe

baseline, after 3, 6 months and after 1 year

Results posted on

2016-07-11

Participant Flow

A total of 195 individuals where screened for eligibility consecutively between October 2009 to April 2011.

Of the 195 eligible participants 124 were ineligible and 4 declined participation..

Participant milestones

Participant milestones
Measure	Controlgroup Instructed to live their ordinary life.	Intervention Group High-Intensity Functional Exercise Program (HIFE) in combination with motivational group discussions two times a week. .
Overall Study STARTED	33	34
Overall Study COMPLETED	29	24
Overall Study NOT COMPLETED	4	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Controlgroup n=33 Participants Ordinary life.	Intervention Group n=34 Participants High Intensity Functional Exercise Program	Total n=67 Participants Total of all reporting groups
Age, Continuous	73.7 years STANDARD_DEVIATION 5.3 • n=5 Participants	72.6 years STANDARD_DEVIATION 5.5 • n=7 Participants	73.1 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment Sweden	33 participants n=5 Participants	34 participants n=7 Participants	67 participants n=5 Participants
Months since stroke	13 months n=5 Participants	13 months n=7 Participants	13 months n=5 Participants

PRIMARY outcome

Timeframe: baseline, after 3, 6 months and after 1 year

Total score on the scale: 0-56 Points. Higher scores indicates better balance.

Outcome measures

Outcome measures
Measure	Controlgroup n=33 Participants Ordinary life.	Intervention Group n=34 Participants High Intensity Functional Exercise Program
The Berg Balance Scale (BBS) BBS change from baseline to 3 months	-0.06 units on a scale Standard Deviation 2.8	4.1 units on a scale Standard Deviation 9.1
The Berg Balance Scale (BBS) BBS change from baseline to 6 months	0.8 units on a scale Standard Deviation 7.9	2.3 units on a scale Standard Deviation 9.5
The Berg Balance Scale (BBS) BBS change from baseline to 15 months	-0.6 units on a scale Standard Deviation 3.4	1.3 units on a scale Standard Deviation 5.4

PRIMARY outcome

Timeframe: Baseline, after 3, 6 months and after 1 year

Total score on the scale: 0-12 Points. Higher scores indicates better functioning. SPPB evaluates balance, gait, strength and endurance by examining an individual's ability to stand with feet together in side-by-side, semi-tandem and tandem positions, time to walk 8 ft and time to rise from a chair and return to the seated position five times.

Outcome measures

Outcome measures
Measure	Controlgroup n=33 Participants Ordinary life.	Intervention Group n=34 Participants High Intensity Functional Exercise Program
Short Physical Performance Battery (SPPB) Mean SPPB change from baseline to 3 months	0.15 units on a scale Standard Deviation 1.1	1.0 units on a scale Standard Deviation 2.8
Short Physical Performance Battery (SPPB) Mean SPPB change from baseline to 6 monnths	0.4 units on a scale Standard Deviation 1.8	0.9 units on a scale Standard Deviation 2.7
Short Physical Performance Battery (SPPB) Mean SPPB change from baseline to 15 months	0.7 units on a scale Standard Deviation 2.4	1.3 units on a scale Standard Deviation 2.4

Adverse Events

Controlgroup

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karin Hellström

UppsalaU

Phone: +46184714762

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place