Condition category
Circulatory System
Date applied
13/03/2015
Date assigned
29/04/2015
Last edited
29/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Stroke is a serious, life-threatening medical condition that usually happens when a blood clot or haemorrhage cuts of the blood supply to an area of the brain. Symptoms vary according to how much of the brain is affected and where in the brain the stroke occurs, but includes paralysis, muscle weakness and speech difficulties. A stroke can also have an impact on the sufferers emotions and can lead to anxiety, depression and personality changes. It is the second leading cause of death and leading cause of long-term neurological disability worldwide. Several rehabilitative interventions (or programmes) have proved to be successful in treating the effects of stroke. They have significantly improved walking speed, physical fitness, balance and reduced the risk for falls, fractures, and further decline in mobility. Recent studies have shown that the degree in which a person is physically active after a stroke affects how disabled the person is. However, there was not enough information to draw reliable conclusions about the impact of fitness training on quality of life or mood. One exercise program that proved to work in improving physical functioning and psychological well-being is the Adaptive Physical Activity (APA), a community-based exercise program for chronic stroke survivors. The effectiveness of APA intervention in combination with Therapeutic Patient Education (TPE) was also investigated in a recent large clinical study in which APA-TPE was compared with treatment as usual (TAU). However, the long-term benefits of the APA TPE are still unknown. The aim of the present study is to find out how well 12 months of Adaptive Physical Activity (APA) combined with Therapeutic Patient Education (TPE) worked in treating stroke survivors.

Who can participate?
Adults (aged at least 18) with a confirmed diagnosis of stroke in the previous 3 to 18 months and able to walk 25m.

What does the study involve?
Participants are allocated (non-randomly) to either the experimental group or control group. Those in the experimental group receive 16 APA sessions and 3 sessions of TPE. Those in the control group receive their usual care. Patients are assessed in terms of distance they are able to walk, how well they are able to perform normal day-to-day activities, whether they feel depressed and the severity of any depression, and their overall perception of how well they have recovered from the stroke 4 months after the beginning of the study. Each participant is also followed up 12 months later to see whether they have suffered any medical complications and what health services they had used in that time.

What are the possible benefits and risks of participating?
Benefits associated with taking part in our study: improvement of physical functioning, ambulatory function, and psychological well-being in patients with stroke. Risks associated with taking part in our study: no significant risk is expected for participants at the APA-TPE program. Physical rehabilitation is supervised by physical therapists. A previous study indicated that no serious adverse clinical events occurred during the APA exercise classes.

Where is the study run from?
The Physical Medicine and Rehabilitation Unit of Sant’Orsola Malpighi Hospital and Physical Medicine and Rehabilitation Unit of IRCCS Santa Maria Nuova in Italy.

When is the study starting and how long is it expected to run for?
January 2009 to May 2012

Who is funding the study?
Regional Agency for Health and Social Care, Regione Emilia-Romagna (Italy)

Who is the main contact?
Dr Simona Calugi
simona.calugi2@unibo.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simona Calugi

ORCID ID

http://orcid.org/0000-0002-4028-1877

Contact details

Via San Giacomo 12
Bologna
40126
Italy
+393471372495
simona.calugi2@unibo.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of adaptive physical activity combined with therapeutic patient education in stroke survivors at 12 months: a non-randomized clinical trial

Acronym

Study hypothesis

The Adaptive Physical Activity (APA) combined with Therapeutic Patient Education (TPE) treatment is more effectiveness than treatment as usual in stroke survivors with mild to moderate hemiparesis recruited after discharge from the hospital, 3 to 18 months after the stroke event

Ethics approval

Ethics Committee of the Hospital Trust Sant’Orsola Malpighi of Bologna and of the Hospital Trust Santa Maria Nuova of Reggio Emilia, 09/09/2009, ref: EFG/2009/01

Study design

Non-randomized clinical trial with concurrent controls

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Stroke survivors

Intervention

The experimental intervention, adapted from the Adaptive Physical Activity (APA) for stroke, developed in Italy and combined with Terapeutic Patient Education (TPE), consisted of 3 group sessions of interactive TPE and 8 weeks of twice-weekly APA exercise sessions. The TPE sessions, held by a physician and physical therapist, involved patients, family, and caregivers. The content included an overview of stroke risk factors, the potential for recovery, how to cope with disabilities, and the benefits of a healthy lifestyle, including APA exercises. The APA exercises include mobility, balance and stretching. TAU comprised recommendations provided in the letter of discharge and two follow-up visits in a year. Two follow-ups were conducted at 4 months by face-to-face interview and at 12 months by telephone interview by blinded assessors.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Change in gait endurance (distance walked) from baseline to 4 months, measured using the 6-minute walk test (6MWT).

Secondary outcome measures

1. The change in the ability to perform activities of daily living measured using the modified Barthel Index
2. The change in the mobility measured using the 6MWT, Short Physical Performance Battery (SPPB), Berg Balance Scale (BBS) and Motricity Index
3. The change of the caregiver’s burden measured using the Caregiver Strain Index
4. The presence and severity of depression measured using the Geriatric Depression Scale
5. The change in the health-related quality of life measured using the 12-item Short-Form Health Survey (SF-12)
6. The patients’ overall perception of their recovery from acute strokes measured using a self-reported visual analog scale (VAS), with a score from 0 to 100

Secondary outcomes included the change of the above mentioned measures from baseline to 4 months and the change from baseline to 12 months of the following measures: Modified Barthel Index; Caregiver Strain Index; Geriatric Depression; SF-12. Moreover, at 12 month follow-up medical complications (presence of falls, fractures, stroke recurrence) and health services utilization (access to the Emergency Department, number of hospitalizations, specialty medical examinations and rehabilitative treatments) were recorded.

Overall trial start date

01/01/2009

Overall trial end date

31/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age ≥18 years
2. A confirmed diagnosis of stroke according to the World Health Organization’s definition in the previous 3 to 18 months, with mild to moderate hemiparesis
3. Ability to walk 25 m independently (with or without an assistive device such as a cane)
4. Discharged home from a rehabilitation center
5. No need to continue physical therapy
6. Informed consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

229 stroke survivors, 3 to 18 months after the stroke event.

Participant exclusion criteria

1. Severe cognitive impairment (Mini-Mental State Examination [MMSE] <15/30 and/or a score >3 on the Disability Communication Scale),
2. Severe heart failure or other medical conditions preventing participation in low-intensity exercise,
3. Co-morbidity (Cumulative Illness Rating Scale [CIRS]: index of comorbidity >3),
4. Severe perceptual disorders (ie, deafness or blindness).

Recruitment start date

01/11/2009

Recruitment end date

31/05/2012

Locations

Countries of recruitment

Italy

Trial participating centre

Physical Medicine and Rehabilitation Unit of Sant’Orsola Malpighi Hospital
Via Pietro Albertoni, 15
Bologna
40138
Italy

Trial participating centre

Physical Medicine and Rehabilitation Unit of IRCCS Santa Maria Nuova
Reggio Emilia
Italy

Sponsor information

Organisation

Regional Agency for Health and Social Care, Regione Emilia-Romagna

Sponsor details

Viale Aldo Moro 21
Bolgna
40127
Italy

Sponsor type

Other

Website

Funders

Funder type

Government

Funder name

Regional Agency for Health and Social Care, Regione Emilia-Romagna

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We would like to publish results about effectiveness of APA-TPE intervention at 12 month follow up in May/June 2015

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes