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.

Study Overview

• Status: Completed
• Conditions: Ischaemic Heart Diseases

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Hospital de Manises

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Adherence to Physical Activity	Registry of the characteristics of physical exercise following the principle: frequency, intensity, time and type of exercise	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.
Participants Adherence to Physical Activity. Steps Control	Registry of daily physical activity, steps per day, by means of an OMROM HJ-321-E pedometer	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Functional Capacity: measurement of ergometer	Incremental of ramp protocol exercise text in a treadmill	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.
Changes in Blood Pressure	Blood pressure recording using an OMROM HcM-FC 31 blood pressure monitor	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
Changes in biochemical variables	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	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.
Changes in abdominal circumference	Registry of centimetres of abdominal circumferene, midpoint from the lower rib margin to the antero-superior iliac crest in standing position, using measuring tape.	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.
Changes in Muscle Mass Index( BMI)	Weight (kg) and height (m) will be recorded	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.
Changes in the perception of quality of life	Registry of the score obtained by means of the SF-12 quality of life questionnaire, in its version adapted and validated in Spanish	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
Changes in anxiety levels	Registry of the score obtained from the State-Trait Anxiety Questionnaire (STAI) in its version adapted and validated in Spanish	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.
Changes in depresión levels	Registry of the score obtained in the Beck Depression Inventory-II (BDI-II) in its version adapted and validated in Spanish	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

Collaborators and Investigators

• Sponsor: Hospital de Manises

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: 2021-132-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No