Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program

NCT ID: NCT03437616

Last Updated: 2024-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Longitudinal controlled study: The intervention group (n=150) participates in Tulppa rehabilitation program and the control group (n=150) do not participate in Tulppa rehabilitation.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tulppa rehabilitation

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

Group Type EXPERIMENTAL

Tulppa rehabilitation

Intervention Type BEHAVIORAL

The intervention includes health education on e.g. healthy diet, weight management, physical activity and psychosocial coping as well as peer discussions and physical exercises.

Control group

Control group does not receive Tulppa rehabilitation during the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tulppa rehabilitation

The intervention includes health education on e.g. healthy diet, weight management, physical activity and psychosocial coping as well as peer discussions and physical exercises.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Finnish Heart Association

UNKNOWN

Sponsor Role collaborator

Rehabilitation Foundation, Finland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erja Poutianen, PhD

Role: STUDY_DIRECTOR

Rehabilitation Foundation

Mila Gustavsson-Lilius, PhD

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation Foundation

Piia Pietilä, MA

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation Foundation

Locations

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Rehabilitation Foundation

Helsinki, Malminkartano, Finland

Site Status

Countries

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Finland

Other Identifiers

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Tulppa-40310

Identifier Type: -

Identifier Source: org_study_id

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