Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program

Rehabilitation Foundation, Finland

Status: Active, not recruiting

Conditions: Coronary Heart Disease

Treatments: Behavioral: Tulppa rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03437616

Tulppa-40310

Details and patient eligibility

About

This study investigates the effectiveness of a Finnish Tulppa outpatient rehabilitation program. Tulppa is a group-based secondary prevention program for patients with vascular diseases. The program is developed by the Finnish Heart Association. The intervention is implemented at the local primary health care centers in 12 health districts in Finland.

A longitudinal controlled study is used to investigate the effects of the intervention on participants' level of cardiovascular risk factors (e.g. lipids, blood pressure, body mass index), functional capacity (e.g. 6 minute walk test), life style as well as psychosocial factors (e.g. smoking, diet, physical activity, health-related quality of life and depression). The data will be collected at baseline (i.e. before the intervention), and 6 and 12 months after the intervention started.

The participants (n = 300) are patients diagnosed with coronary heart disease. The study group (n = 150) is recruited from participants of Tulppa rehabilitation in three health care districts (Pirkanmaa, South Karelia, Päijät-Häme). The control group (n = 150) is recruited from two health care districts (Turku and Hyvinkää) that do not provide Tulppa rehabilitation.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Study group: Patients diagnosed with coronary heart disease taking part in the Tulppa cardiac rehabilitation program at Pirkanmaa, South Karelia and Päijät-Häme health districts
• Control group: Patients diagnosed with coronary heart disease, living in the area of Turku or Hyvinkää which are health districts that do not provide Tulppa rehabilitation.

Exclusion criteria

• Acute and severe mental health problems, alcohol abuse, major limitations in physical activities

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Tulppa rehabilitation

Experimental group

Description:

8-10 weekly 3-hour group sessions and two follow-up sessions (6 and 12 months).

Treatment:

Behavioral: Tulppa rehabilitation

Control group

No Intervention group

Description:

Control group does not receive Tulppa rehabilitation during the study.