Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program

Coronary Heart Disease Clinical Trial

Official title:

Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program - a Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03437616
• Other study ID #: Tulppa-40310
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: December 2029

Study information

• Verified date: November 2021
• Source: Rehabilitation Foundation, Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2029
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Finland	Rehabilitation Foundation	Helsinki	Malminkartano

Sponsors (2)

Lead Sponsor	Collaborator
Rehabilitation Foundation, Finland	Finnish Heart Association

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Family support	Partner support will be measured with a Finnish 12-item Family Support (FS) scale (Julkunen & Greenglass, 1989; Gustavsson-Lilius M., Julkunen J., & Hietanen P., 2007). The items are rated using a five-step Likert scale (1 = completely disagree… 5 = completely agree) and the range of the total score is 12 - 60. The sum-score of the scale reflects the respondents' perceived degree of emotional and instrumental support received from other family members. Higher scores on the scale indicates higher amount of perceived support from the family.	Baseline, 6 months and twelve months
Primary	Health related quality of life	Health related quality of life is assessed with the finnish version of RAND-36-Item Health Survey (36-Item Short Form Survey Instrument - SF-36; Aalto, Aro & Teperi, 1999). The RAND-36 is a generic health-related survey consisting of 36 items with eight sub-scales: 1. general health, 2. bodily pain, 3. physical functioning, 4. role limitations/physical, 5. role limitations/emotional, 6. vitality, 7. mental health, and 8. social functioning. The total score is a sum of the eight subscales and the range is 0 - 100. Higher scores on the scale indicate a better quality of life.	Changes between baseline, 6 months and 12 months
Primary	Modified North Karelia CVD risk score	The limit values to calculate the CVD risk score were originally developed during the North Karelia project (Puska et al., 2009) and were further elaborated by Ketola (2001). The modified CVD risk score consists of six risk factors: Body mass index (BMI); Smoking; Physical inactivity; Systolic blood pressure; Diastolic blood pressure; Total cholesterol. The total score of the index is a sum of the 6 risk factors and the range is 0-16, the cut-off point indicating high risk of CVD is 4.5. Higher scores on the scale indicate a higher risk of cardiovascular disease. Subscore outcomes of the CVD risk score are defined as secondary outcome measures below.	Changes between baseline, 6 months and 12 months
Secondary	The 6-Min Walk Test	The 6-min Walk Test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.	Changes between baseline, 6 months and 12 months
Secondary	Blood pressure	Blood pressure is expressed in terms of the systolic and diastolic pressure and is measured in millimeters of mercury (mmHg).	Changes between baseline, 6 months and 12 months
Secondary	Waist circumference	Waist circumference is measured halfway between the costal margin and iliac crest in centimeters.	Changes between baseline, 6 months and 12 months
Secondary	Body mass index	The body mass index (BMI) is calculated as weight in kilograms divided by height in meters squared (kg/m2).	Changes between baseline, 6 months and 12 months
Secondary	Lipid profile	Triglycerides, LDL-, HDL- and total cholesterol level will be measured with laboratory test	Changes between baseline, 6 months and 12 months
Secondary	Blood glucose level	Fasting plasma glucose (mmol/l) will be measured with laboratory test	Changes between baseline, 6 months and 12 months
Secondary	Physical inactivity	Physical inactivity is assessed with one question about the frequency per week of physical exercise causing swetting and /or some shortness of breath (1 = 3 or more times/week, 2 = 1-2 times/week, 3 = 1 time/week, 4 = sometimes, 5 = never)	Changes between baseline, 6 months and 12 months
Secondary	Smoking	Smoking is evaluated with one question about number of cigarettes/day (0 = not at all...8 = 30 or more cigarettes/day)	Changes between baseline, 6 months and 12 months
Secondary	Alcohol use	Alcohol use is measured with two questions: How often do you have drinks containing alcohol? (0 = never, 1 = monthly or less, 2 = 2-4 times a month, 3 = 2-3 times a week, 4 = 4 times a week or more); How many drinks containing alcohol do you have on a typical day when you are drinking? (1 = 1-2 drinks, 2 = 3-4, 3 = 5-6, 4 = 7-9, 5 = 10 drinks or more)	Changes between baseline, 6 months and 12 months
Secondary	Dietary habits	Dietary habits are evaluated with 3 questions: Do you eat regular meals? (2 = yes, 1 = I don´t know, 0 = no) Do you use low-fat foods? (2 = yes, 1 = I don´t know, 0 = no) Do you eat enough good / healthy fat? (2 = yes, 1 = I don´t know, 0 = no)	Changes between baseline, 6 months and 12 months
Secondary	Depression	Depression will be measured using The finnish Depression Scale DEPS (Salokangas, R. K., Poutanen, O & Stengard, E.,1995). 10 items, the items are rated from 0 to 3 (0 = not at all... ...3 = very much) and the range of the total score is 0-30. Higher scores on the scale indicate a higher probability of depression.	Changes between baseline, 6 months and 12 months
Secondary	Anxiety	Anxiety will be assessed with the state-anxiety sub-scale of the Endler Multidimensional Anxiety Scales (EMAS-State) (Endler, N. S., Parker, J. D. A., Bagby, R. M., & Cox, B. J., 1991). The State-anxiety sub-scale consists of 20 items evaluated on a five-point Likert scale (score range 20-100). EMAS-State assesses two components of state-anxiety : a cognitive worry component and an autonomic-emotional component. Both components consist of ten items. In this study the 10 items of a cognitive worry component is used. Higher scores indicate a higher level of cognitive worry.	Changes between baseline, 6 months and 12 months