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Coronary Heart DiseaseNCT03437616

Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program

A study testing Tulppa rehabilitation in people with Coronary Heart Disease, run by Rehabilitation Foundation, Finland at 1 site in Finland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Heart Disease
What is being tested?
Tulppa rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteFinland
Study dates
19 Feb 2018to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Acute and severe mental health problems, alcohol abuse, major limitations in physical activities

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Rehabilitation Foundation

    Helsinki, Malminkartano, 00410

Other trials in Finland

About this study

Official title: 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.

Being tested
Tulppa rehabilitation
Keywords
Rehabilitation, Coronary heart disease, Cardiovascular diseases, Risk factors, Life-style changes, Efficacy
Medical subject headings
Coronary Disease, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tulppa rehabilitationBehavioural

    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.

Study groups in NCT03437616
Study groupRoleWhat they receive
Tulppa rehabilitationExperimental8-10 weekly 3-hour group sessions and two follow-up sessions (6 and 12 months).
Receives: Behavioral: Tulppa rehabilitation
Control groupNo interventionControl group does not receive Tulppa rehabilitation during the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Changes between baseline, 6 months and 12 months

  2. 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:

    1. Body mass index (BMI)
    2. Smoking
    3. Physical inactivity
    4. Systolic blood pressure
    5. Diastolic blood pressure
    6. 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.

    Measured: Changes between baseline, 6 months and 12 months

Secondary outcomes (12)

  1. 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.

    Measured: Changes between baseline, 6 months and 12 months

  2. Blood pressure

    Blood pressure is expressed in terms of the systolic and diastolic pressure and is measured in millimeters of mercury (mmHg).

    Measured: Changes between baseline, 6 months and 12 months

  3. Waist circumference

    Waist circumference is measured halfway between the costal margin and iliac crest in centimeters.

    Measured: Changes between baseline, 6 months and 12 months

  4. Body mass index

    The body mass index (BMI) is calculated as weight in kilograms divided by height in meters squared (kg/m2).

    Measured: Changes between baseline, 6 months and 12 months

  5. Lipid profile

    Triglycerides, LDL-, HDL- and total cholesterol level will be measured with laboratory test

    Measured: Changes between baseline, 6 months and 12 months

  6. Blood glucose level

    Fasting plasma glucose (mmol/l) will be measured with laboratory test

    Measured: Changes between baseline, 6 months and 12 months

  7. 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)

    Measured: Changes between baseline, 6 months and 12 months

  8. Smoking

    Smoking is evaluated with one question about number of cigarettes/day (0 = not at all...8 = 30 or more cigarettes/day)

    Measured: Changes between baseline, 6 months and 12 months

  9. Alcohol use

    Alcohol use is measured with two questions:

    1. 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)
    2. 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)

    Measured: Changes between baseline, 6 months and 12 months

  10. 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)

    Measured: Changes between baseline, 6 months and 12 months

  11. 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.

    Measured: Changes between baseline, 6 months and 12 months

  12. 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.

    Measured: Changes between baseline, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start19 Feb 2018
  3. Primary completion14 Dec 2020
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03437616
Sponsor's protocol ID
Tulppa-40310
Status last verified
Jul 2024
First submitted
10 Jan 2018
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Tulppa rehabilitation in people with Coronary Heart Disease, run by Rehabilitation Foundation, Finland at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health related quality of life (time frame: Changes between baseline, 6 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03437616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.

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