Maintenance of Physical Activity After Cardiac Rehabilitation

Not Applicable

• Conditions: Myocardial Ischemia; Heart Failure; Heart Diseases; Arrythmia; Heart Arrest; Cardiovascular Diseases
• Interventions: Behavioral: Maintenance intervention

• Registration Number: NCT05011994
• Lead Sponsor: Slagelse Hospital

Brief Summary

Physical activity is a key element in cardiac rehabilitation and prevention of cardiovascular mortality and hospitalizations. After cardiac rehabilitation programs end, physical activity levels and participation in continued cardiac rehabilitation declines. The aim of this study is to evaluate the feasibility a mobile health intervention with text messages and behavior change theory in patients with cardiovascular disease for a duration of 3 months after completion of a cardiac rehabilitation program. An intervention consisting of action planning, text messages, and coordinator support is tested in a feasibility trial design with 40 expected participants.

Detailed Description

Physical activity is a key element in cardiac rehabilitation and prevention of cardiovascular mortality and hospitalizations. After cardiac rehabilitation programs end, physical activity levels and participation in continued cardiac rehabilitation declines.

The primary aim of this study is to evaluate the feasibility in terms of recruitment, retention, data completeness, intervention delivery and compliance, and acceptability of a mobile health intervention with text messages and behavior change theory in patients with cardiovascular disease for a duration of 3 months after completion of a cardiac rehabilitation program.

The study is a single-group multi-site feasibility trial. Participants will be recruited from phase II cardiac rehabilitation programs at Slagelse Hospital, the city of Slagelse (municipality), and Holbæk Hospital. Starting immediately after completion of cardiac rehabilitation, study participants will receive an intervention that consists of action planning, text messages, and coordinator support for a period of 12 weeks (see more details under 'Arms and Interventions'). The investigators base the intervention on a theoretical model of behavior change in the form of the Health Action Process Approach (HAPA). Behavior change techniques (BCTs) are used as part of the intervention. The intervention is an addition to standard practice and does not replace any existing treatment offers.

To evaluate the feasibility of the intervention and its readiness to be tested in a subsequent RCT design, the investigators have set progression criteria using a system of green (proceed to RCT), amber (amend when proceeding to RCT), or red (issue must be solved before proceeding to RCT). The progression criteria are listed under 'Primary Outcome Measures'.

Participants will wear accelerometers on thigh and wrist for 1 and 3 weeks, respectively, starting 1 week before end of cardiac rehabilitation. Baseline measurements and start of intervention is planned to be at the same time as cardiac rehabilitation ends. After 11 weeks of intervention, participants will attend a follow-up assessment, where participants will wear accelerometers on thigh and wrist again.

Study Timeline

• Study First Submitted: 2021-07-17
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-19
• Study Start: 2021-08-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-14
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age ≥18 years.
• Participant in an exercise-based cardiac rehabilitation program in either hospital or municipality setting.
• Access to a personal mobile phone and Danish telephone number.
• Able to walk 3 meters without assistance.

Exclusion Criteria

• Insufficient Danish language proficiency to read and understand text messages and questionnaires.
• Patients cognitively or mentally unable to participate.
• Terminal patients and patients with a life expectancy of less than 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maintenance intervention	Maintenance intervention	Participants will receive a 12-week mobile health (mHealth) intervention that consists of action planning, text messages, and coordinator support.

Primary Outcome Measures

Name	Time	Method
Coordinator time spent, minutes per participant throughout the intervention	12 weeks	Green: Mean coordinator time spent of ≤30 minutes per participant; Amber: Mean coordinator time spent of 31-60 minutes per participant; Red: Mean coordinator time spent of \>60 minutes per participant
Attrition/retention through follow-up assessment session	Up to 12 weeks	Green: ≥80% retention of participants through follow up; Amber: 50-79% retention of participants through follow up; Red: \<50% retention of participants through follow up
Accelerometer data completeness	12 weeks	Green: Accelerometer data from both baseline and follow-up available on ≥80% of completing participants; Amber: Data available on 50-79% of completing participants; Red: Data available on \<50% of completing participants
Acceptability of text message component, single item	12 weeks	Green: ≥75% of participants find text messages acceptable; Amber: 50-74% of participants find text messages acceptable; Red: \<50% of participants find text messages acceptable
Recruitment	Baseline	Green: Mean of ≥0.75 recruited participants per week per site; Amber: Mean of 0.5-0.74 recruited participants per week per site; Red: Mean of \<0.5 recruited participants per week per site
Response rate on patient reported outcomes	12 weeks	Green: ≥90% of participants attending baseline and follow-up assessment return patient reported outcomes; Amber: 75-89% of patients attending baseline and follow-up assessment return patient reported outcomes; Red: \<75% of participants attending baseline and follow-up assessment return patient reported outcomes
Response rate (adherence) to weekly follow-up messages	12 weeks	Green: ≥75% of patients respond to at least 75% of messages; Amber: 50-74% of patients respond to at least 75% of messages; Red: \<50% of patients respond to at least 75% of messages

Secondary Outcome Measures

Name	Time	Method
Physical activity, objectively measured	Change from baseline to 12 weeks	Measured with thigh and wrist accelerometers
Physical function, sit-to-stand	Change from baseline to 12 weeks	30-second sit-to-stand test
Physical function, walking	Change from baseline to 12 weeks	6 minute walking test
Physical activity, subjectively measured	Change from baseline to 12 weeks	The International Physical Activity Questionnaire (IPAQ) is used to measure physical activity in the past 7 days. 0 is minimum (completely inactivty).

Trial Locations

Locations (3)

Holbæk Hospital; 🇩🇰 Holbæk, Denmark

Slagelse Hospital; 🇩🇰 Slagelse, Denmark

City of Slagelse (municipality); 🇩🇰 Korsør, Denmark