The feasibility of the use of behaviour change techniques to promote physical activity of acute stroke patients during hospitalization – a pilot randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00032238

Enrollment

Registered

2023-07-11

Start date

2023-07-19

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I64

Interventions

Group 1: Three-part intervention a. Eduction The educational part of the intervention aims to provide information to the participants of the intervention group. The participants receive an information

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: diagnosis of stroke/TIA in the last 48 hours NIHSS 0-5 Physiotherapy prescription Mobilisation out of bed allowed intact speech comprehension complete orientation independent mobility with or without aids, before and after stroke

Exclusion criteria

Exclusion criteria: no diagnosis of stroke/TIA stroke/TIA more than 48 hours ago NIHSS >5 no physiotherapy prescription limited mobilization out of bed because of medical reasons limited speech comprehension orientation unclear no independent mobility

Design outcomes

Primary

Measure	Time frame
For the primary focus of feasibility the recruitment rate, retention, adherence, safety and acceptance are evaluated. Recruitment will be monitored to determine how many patients per group and week meet the inclusion criteria and can be enrolled in the study. The percentage of participants between the first measurement and the completion of the second measurement will be compared to assess retention and dropout. Adherence to the intervention is defined as the percentage of the total hospital stay during which the accelerometer was worn. The safety aspect of the intervention is determined by the number of adverse events. Adverse events are defined as the number of falls recorded for both groups. In addition, all discontinuations due to feelings of insecurity are noted to capture acceptability.	—

Measure

Time frame

For the primary focus of feasibility the recruitment rate, retention, adherence, safety and acceptance are evaluated. Recruitment will be monitored to determine how many patients per group and week meet the inclusion criteria and can be enrolled in the study. The percentage of participants between the first measurement and the completion of the second measurement will be compared to assess retention and dropout. Adherence to the intervention is defined as the percentage of the total hospital stay during which the accelerometer was worn. The safety aspect of the intervention is determined by the number of adverse events. Adverse events are defined as the number of falls recorded for both groups. In addition, all discontinuations due to feelings of insecurity are noted to capture acceptability.

—

Secondary

Measure	Time frame
The effects of using a combination of BCTs will be determined using the following outcome measures: the recording of light, moderate and heavy physical activity by an accelerometer and the assessment of mobility by the De Morton Mobility Index. This will be collected before randomisation and again before participants are discharged.	—

Countries

Germany

Contacts

Public ContactChristian Grüneberg

Hochschule für Gesundheit

christian.grueneberg@hs-gesundheit.de+4923477727620

Outcome results

None listed

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