Clinical trial NCT03437616: Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program
Official title: Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program - a Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Rehabilitation
Coronary heart disease
Cardiovascular diseases
Risk factors
Life-style changes
Efficacy
Lead sponsor: Rehabilitation Foundation, Finland
Sponsor class: OTHER
Collaborators: name: Finnish Heart Association
First posted: 2018-02-19
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Health related quality of life
timeFrame: Changes between baseline, 6 months and 12 months
measure: Modified North Karelia CVD risk score
timeFrame: Changes between baseline, 6 months and 12 months
Secondary outcomes:
measure: The 6-Min Walk Test
timeFrame: Changes between baseline, 6 months and 12 months
measure: Blood pressure
timeFrame: Changes between baseline, 6 months and 12 months
measure: Waist circumference
timeFrame: Changes between baseline, 6 months and 12 months
measure: Body mass index
timeFrame: Changes between baseline, 6 months and 12 months
measure: Lipid profile
timeFrame: Changes between baseline, 6 months and 12 months
measure: Blood glucose level
timeFrame: Changes between baseline, 6 months and 12 months
measure: Physical inactivity
timeFrame: Changes between baseline, 6 months and 12 months
measure: Smoking
timeFrame: Changes between baseline, 6 months and 12 months
measure: Alcohol use
timeFrame: Changes between baseline, 6 months and 12 months
measure: Dietary habits
timeFrame: Changes between baseline, 6 months and 12 months
measure: Depression
timeFrame: Changes between baseline, 6 months and 12 months
measure: Anxiety
timeFrame: Changes between baseline, 6 months and 12 months
Other outcomes:
measure: Family support
timeFrame: Baseline, 6 months and twelve months
Locations:
city: Helsinki
country: Finland
facility: Rehabilitation Foundation
state: Malminkartano
Study officials:
affiliation: Rehabilitation Foundation
name: Erja Poutianen, PhD
role: STUDY_DIRECTOR
affiliation: Rehabilitation Foundation
name: Mila Gustavsson-Lilius, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rehabilitation Foundation
name: Piia Pietilä, MA
role: PRINCIPAL_INVESTIGATOR
References: