Long-term effect of physical activity intervention promoting autonomous practice

• Register: ISRCTN
• Last refreshed on: 9 January 2023
• Main ID: ISRCTN77313697
• Date of registration: 20/11/2015
• Prospective Registration: No
• Primary sponsor: Lamhess
• Public title: Long-term effect of physical activity intervention promoting autonomous practice
• Scientific title: Protocol of the “As du Coeur” study: A randomized controlled trial on the maintenance of physical activity for cardiovascular patients
• Date of first enrolment: 10/07/2014
• Target sample size: 50
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN77313697
• Study type: Interventional
• Study design: Multi-centre interventional randomized controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

France

Contacts

• Name: Marion Fournier

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 18 years or over
2. Registered with chronic disease (cardiovascular disease or cardiac deficiency)
3. Considered as sedentary according to the brief physical activity assessment
4. Absence of contraindication to PA stated by a cardiologist
5. Possibility to attend a fitness center for a 60-min session twice a week

Exclusion criteria: Contraindication to PA stated by a cardiologist.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular disease
Circulatory System
Cardiovascular disease

Intervention(s)

Cardiovascular patients will be individually randomized in two groups.

Group 1: Participants will have two supervised physical activity sessions per week for 20 weeks. They will receive two supervised sessions over a period of 5 months., including one session of one hour of cardio-training and one session of one hour of nordic walking. Patients will also be recommended to do at least one more session on their own during the week to match with the American College of sports medicine (ACSM) guidelines for cardiac patients.

Group 2: Participants will have the same supervised intervention for the first 10 weeks and one supervised session will be replaced by an encouragement for autonomous practice of physical activity (written material and regular phone call) in the last 10 weeks.

The follow-up involves participants to answer to the International Physical Activity Questionnaire by phone at baseline, 5, 7 and 9 months. Eventually, they will have to participate to the final evaluation at 12 months for physical and psychological measures.

Primary Outcome(s)

Level of physical activity measured using the International Physical activity questionnaire at baseline, 5, 7, 9 and 12 months.

Secondary Outcome(s)

1. Motivation regarding physical activity is measured using the sport motivation scale at baseline, 5 and 12 months
2. Automaticity of physical activity behaviour is measured using Self Report Behavioral Automaticity Index at baseline, 5 and 12 months
3. Quality of life is measured at baseline, 5 and 12 months
4. Physical condition of the patient is measured using the SF-36 questionnaire at baseline, 5 and 12 months
5. Economic evaluation is measured using The Quality adjusted Life Years (QALY) at baseline, 5 and 12 months

Secondary ID(s)

N/A

Source(s) of Monetary Support

Malakoff Mederick Group

Ethics review

Status:
Approval date:
Contact:

1. "Comité de Protection des Personnes" (National ethical committee for human research), 16/12/2014, ref: 14 073 2. "Agence Nationale de la Sécurité et des Médicaments" (National drug agency), 15/12/2014, ref: 141299B-21

Results

• Results available: Yes
• Date Completed: 02/02/2016