Clinical trial NCT06599034: Strategies to Increase Adherence to Physical Activity in a Phase III Cardiac Rehabilitation Program
Official title: Strategies to Increase Adherence to Physical Activity in a Phase III Cardiac Rehabilitation Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischaemic Heart Diseases
Lead sponsor: Hospital de Manises
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is all patients with ischaemic heart disease who have completed phase II in the Cardiac Rehabilitation Service of Centro de Especialidades Mislata, Hospital Manises.

The final sample is made up of patients who have completed all the sessions of the cardiac rehabilitation programme (20 sessions for high-moderate risk patients, 16 sessions for low-risk patients) and meet all the inclusion criteria and none of the exclusion criteria.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Adherence to Physical Activity
timeFrame: 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.
measure: Participants Adherence to Physical Activity. Steps Control
timeFrame: 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).
Secondary outcomes:
measure: Changes in Functional Capacity: measurement of ergometer
timeFrame: 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.
measure: Changes in Blood Pressure
timeFrame: 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
measure: Changes in biochemical variables
timeFrame: 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.
measure: Changes in abdominal circumference
timeFrame: 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.
measure: Changes in Muscle Mass Index( BMI)
timeFrame: 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.
measure: Changes in the perception of quality of life
timeFrame: 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
measure: Changes in anxiety levels
timeFrame: 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.
measure: Changes in depresión levels
timeFrame: 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
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital de Manises
Study officials:
References: