Effectiveness of adaptive physical activity combined with therapeutic patient education in stroke survivors at 12 months.

• Register: ISRCTN
• Last refreshed on: 11 February 2019
• Main ID: ISRCTN10249582
• Date of registration: 29/04/2015
• Prospective Registration: No
• Primary sponsor: Regional Agency for Health and Social Care, Regione Emilia-Romagna
• Public title: Effectiveness of adaptive physical activity combined with therapeutic patient education in stroke survivors at 12 months.
• Scientific title: Effectiveness of adaptive physical activity combined with therapeutic patient education in stroke survivors at 12 months: a non-randomized clinical trial
• Date of first enrolment: 01/11/2009
• Target sample size: 229
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10249582
• Study type: Interventional
• Study design: Non-randomized clinical trial with concurrent controls (Other)

Countries of recruitment

Italy

Contacts

• Name: Simona Calugi

Key inclusion & exclusion criteria

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

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).


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke survivors
Circulatory System

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

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

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 31/05/2012