Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Behavioral: Tulppa rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Malminkartano
    • Helsinki, Malminkartano, Finland, 00410
      • Rehabilitation Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tulppa rehabilitation; 8-10 weekly 3-hour group sessions and two follow-up sessions (6 and 12 months).	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.
No Intervention: Control group; Control group does not receive Tulppa rehabilitation during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Waist circumference	Waist circumference is measured halfway between the costal margin and iliac crest in centimeters.	Changes between baseline, 6 months and 12 months
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
Lipid profile	Triglycerides, LDL-, HDL- and total cholesterol level will be measured with laboratory test	Changes between baseline, 6 months and 12 months
Blood glucose level	Fasting plasma glucose (mmol/l) will be measured with laboratory test	Changes between baseline, 6 months and 12 months
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rehabilitation Foundation, Finland
• Collaborators: Finnish Heart Association
• Investigators: Study Director: Erja Poutianen, PhD, Rehabilitation Foundation; Principal Investigator: Mila Gustavsson-Lilius, PhD, Rehabilitation Foundation; Principal Investigator: Piia Pietilä, MA, Rehabilitation Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Actual): December 14, 2020
• Study Completion (Anticipated): December 1, 2029

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Efficacy; Coronary heart disease; Risk factors; Cardiovascular diseases; Life-style changes
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: Tulppa-40310

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No