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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10249582

Enrollment

229

Registered

2015-04-29

Start date

2009-11-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke survivors Circulatory System

Interventions

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 i

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: 1. Severe cognitive impairment (Mini-Mental State Examination [MMSE] 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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026