Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT03437616
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2018-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program
Sponsor:
Rehabilitation Foundation, Finland
Organization:
Study Overview
Official Title:
Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program - a Controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: