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

NCT06599034 | Completed

• 1 other identifier: 2021-132-1
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischaemic Heart Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Changes in Functional Capacity: measurement of ergometer

  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

  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

  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

  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)

  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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Older 70 years old

Sponsors & Collaborators

• Hospital de Manises: lead

Study Sites (1)

Hospital de Manises

Valencia, Valencia, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: October 4, 2022
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)