Cardiovascular Rehabilitation - Effectiveness of the Tulppa Program

NCT03437616 | Active Not Recruiting

• 1 other identifier: Tulppa-40310
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

Rehabilitation; Coronary heart disease; Cardiovascular diseases; Risk factors; Life-style changes; Efficacy

Outcome Measures

Primary Outcomes (2)

• 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: 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.

  Changes between baseline, 6 months and 12 months

Secondary Outcomes (12)

• The 6-Min Walk Test

  Changes between baseline, 6 months and 12 months

• Blood pressure

  Changes between baseline, 6 months and 12 months

• Waist circumference

  Changes between baseline, 6 months and 12 months

• Body mass index

  Changes between baseline, 6 months and 12 months

• Lipid profile

  Changes between baseline, 6 months and 12 months

Other Outcomes (1)

• Family support

  Baseline, 6 months and twelve months

Study Arms (2)

Tulppa rehabilitation

EXPERIMENTAL

8-10 weekly 3-hour group sessions and two follow-up sessions (6 and 12 months).

Behavioral: Tulppa rehabilitation

Control group

NO INTERVENTION

Control group does not receive Tulppa rehabilitation during the study.

Interventions

Tulppa rehabilitation BEHAVIORAL

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.

Tulppa rehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rehabilitation Foundation, Finland: lead
• Finnish Heart Association: collaborator

Study Sites (1)

Rehabilitation Foundation

Helsinki, Malminkartano, 00410, Finland

Location

MeSH Terms

Conditions

Coronary Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Study Officials

• Erja Poutianen, PhD

  Rehabilitation Foundation

  STUDY DIRECTOR

• Mila Gustavsson-Lilius, PhD

  Rehabilitation Foundation

  PRINCIPAL INVESTIGATOR

• Piia Pietilä, MA

  Rehabilitation Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: February 19, 2018
• Study Start: February 19, 2018
• Primary Completion: December 14, 2020
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

FI (1)