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Completed

NCT Number: NCT06599034

Strategies to Increase Adherence to Physical Activity in a Phase III Cardiac Rehabilitation Program

This study consists of a randomised clinical trial of two parallel groups conducted in patients with ischaemic heart disease after completing phase II of Cardiac Rehabilitation (RHBC) at the Centro de Especialidades Mislata (CEM),Hospital Manises. The objective is to assess adherence to structured and unstructured physical activity in the long term (6 and 12 months). In addition to the usual recommendations in the Control Group (CG), a motivational programme will be added to the Intervention Group (IG), which will consist of establishing an individualised exercise plan reviewed monthly, in addition to maintaining continuous contact with the physiotherapist.

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Key information

Conditions

Ischaemic Heart Diseases Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Manises

Valencia, Spain

About this study

Regular physical activity is an important measure in the prevention of cardiovascular diseases. In the phase II Cardiac Rehabilitation programme, the acquisition of healthy lifestyle habits is taught and encouraged, with physical exercise as a fundamental pillar of the programme. Physical exercise should be maintained throughout life (RHBC phase III) in order to continue to produce cardiovascular benefits. However, few studies focus on strategies to increase adherence to physical activity, despite its benefits in disease control.

Motivation is one of the main barriers described by patients as well as the lack of contact with healthcare staff once the acute disease process is over. Therefore, we propose a simple, practical and economical intervention to increase adherence to physical activity, through a motivational programme, based on the establishment of objectives for each patient, carrying out an individualised physical exercise programme according to their preferences and needs, also establishing continuous contact with the physiotherapist to review and establish new objectives.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ischaemic heart disease who have completed phase II of cardiac rehabilitation in CEM.
  • Patients of both sexes.
  • Patients classified as low, medium and high risk
  • Age between 18 and 70 years at the time of the cardiac event.

Exclusion criteria

  • Older 70 years old

Treatment and study plan

Primary outcomes

  1. Patient Adherence to Physical Activity

    Time frame: The groups, CG ad IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP.

    Registry of the characteristics of physical exercise following the principle: frequency, intensity, time and type of exercise

  2. Participants Adherence to Physical Activity. Steps Control

    Time frame: The groups, control group (CG) and intervention group (IG), will be assessed at two times, 6 months and 12 months after the finish phase II of cardiac rehabilitation program (CRP).

    Registry of daily physical activity, steps per day, by means of an OMROM HJ-321-E pedometer

Secondary outcomes

  1. Changes in Functional Capacity: measurement of ergometer

    Time frame: The groups, CG and IG, will be assessed at three times: at baseline, at finish phase II cardiac rehabilitation program, at 12 months after the finish phase II CRP.

    Incremental of ramp protocol exercise text in a treadmill

  2. Changes in Blood Pressure

    Time frame: The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP

    Blood pressure recording using an OMROM HcM-FC 31 blood pressure monitor

  3. Changes in biochemical variables

    Time frame: The groups, CG and IG, will be assessed at three times: at baseline, at finish phase II cardiac rehabilitation program, at 12 months after the finish phase II CRP.

    Registry of the values of total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, basal glycaemia and glycosylated haemoglobin to be analysed by means of a blood test

  4. Changes in abdominal circumference

    Time frame: The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP.

    Registry of centimetres of abdominal circumferene, midpoint from the lower rib margin to the antero-superior iliac crest in standing position, using measuring tape.

  5. Changes in Muscle Mass Index( BMI)

    Time frame: The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP.

    Weight (kg) and height (m) will be recorded

  6. Changes in the perception of quality of life

    Time frame: The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP

    Registry of the score obtained by means of the SF-12 quality of life questionnaire, in its version adapted and validated in Spanish

  7. Changes in anxiety levels

    Time frame: The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP.

    Registry of the score obtained from the State-Trait Anxiety Questionnaire (STAI) in its version adapted and validated in Spanish

  8. Changes in depresión levels

    Time frame: The groups, CG and IG, will be assessed at four times: at baseline, at finish of the phase II CRP, at 6 months after the finish phase II CRP and at 12 months after the finish of phase II CRP

    Registry of the score obtained in the Beck Depression Inventory-II (BDI-II) in its version adapted and validated in Spanish

Sponsors and collaborators

Lead sponsor

Hospital de Manises

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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