Maintenance of Physical Activity After Cardiac Rehabilitation (FAIR)

Maintenance of Physical Activity After Cardiac Rehabilitation: a Feasibility Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Arrest; Arrythmia
• Intervention / Treatment: Behavioral: Maintenance intervention

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rune M Andersen, PhD; Phone Number: +4558559790 +4529623522; Email: ruma@regionsjaelland.dk
• Study Contact Backup: Name: Lars H Tang, PhD; Phone Number: +4558559790; Email: larta@regionsjaelland.dk

Study Locations

• Denmark
  • Holbæk, Denmark, 4300
    • Recruiting
    • Holbæk Hospital
  • Korsør, Denmark, 4220
    • Recruiting
    • City of Slagelse (municipality)
  • Slagelse, Denmark, 4200
    • Recruiting
    • Slagelse Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Behavioral: Maintenance intervention; The intervention consists of action planning, text messages, and coordinator support. At onset, each participant creates an action plan for physical activity with the help of a health professional: What types of physical activities?; When and how often?; Where and with who?2 auto-generated text messages are sent weekly for a duration of 12 weeks. The first prompts physical activity. The second asks if plans were reached. If yes, an automatic reply with positive reinforcement is generated. If no, an automatic reply asks if the participant wants to be contacted. Participants are contacted by a coordinator either by answering text messages or if not answering the texts for a period of 2 weeks or more. Coordinator functions: Call participants replying to texts that they wish to be contacted; Help participants establish contact to local activities involving physical activity; Follow-up on and adjustment of action plan; Offer guidance in physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	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	Baseline
Attrition/retention through follow-up assessment session	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	Up to 12 weeks
Accelerometer data completeness	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	Baseline
Accelerometer data completeness	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	12 weeks
Response rate on patient reported outcomes	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	Baseline
Response rate on patient reported outcomes	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	12 weeks
Coordinator time spent, minutes per participant throughout the intervention	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	12 weeks
Response rate (adherence) to weekly follow-up messages	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	12 weeks
Acceptability of text message component, single item	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	12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life, general	EQ-5D-5L evaluates health status in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 1 (best) to 5 (worst) and overall health is rated on a 0 to 100 VAS scale.	Change from baseline to 12 weeks
Health-related quality of life, VAS subscale	EQ-5D-5L evaluates health status in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 1 (best) to 5 (worst) and overall health is rated on a 0 to 100 VAS scale.	Change from baseline to 12 weeks
Health-related quality of life, heart-specific	HeartQoL is used to measure heart-specific quality of life in the past 4 weeks. Range from 0 (worst) to 42 (best) .	Change from baseline to 12 weeks
Anxiety and depression	Hospital Anxiety and Depression Scale (HADS). HADS gives a score for each of anxiety and depression, each ranging from 0 (best) to 21 (worst).	Change from baseline to 12 weeks
Physical function, self-reported	WHO Disability Assessment Schedule 2.0 (WHODAS 2.0),12-item version. WHODAS is a generic assessment instrument for health and disability. Range from 12 (no disability) to 60 (highest disability or loss of function).	Change from baseline to 12 weeks
Comorbidity	Disease Burden: Morbidity Assessment by Self-Report used to evaluated a list of common chronic conditions affect the participants' daily activities. Each condition (that the participant has) is rated from 1 (not at all) to 5 (a lot) in regard to how much it limits daily activities.	Change from baseline to 12 weeks
Self-efficacy, managing chronic disease	Self-efficacy of managing chronic disease 6 items scale. Score is calculated as the mean of 6 items, each scored from 1 (low self-efficacy) to 10 (high self-efficacy).	Change from baseline to 12 weeks
Motivational Self-efficacy	Motivational self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).	Change from baseline to 12 weeks
Coping Self-efficacy	Coping self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).	Change from baseline to 12 weeks
Recovery Self-efficacy	Recovery self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).	Change from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Slagelse Hospital
• Collaborators: University of Southern Denmark; Holbaek Sygehus; University College Copenhagen; City of Slagelse (municipality)
• Investigators: Principal Investigator: Rune M Andersen, PhD, Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark; Study Chair: Lars H Tang, PhD, Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark; Study Chair: Søren T Skou, PhD, Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark

Publications and helpful links

General Publications

• Andersen RM, Skou ST, Clausen MB, Jager M, Zangger G, Grontved A, Brond JC, Soja AMB, Tang LH. Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial. BMJ Open. 2022 Apr 5;12(4):e060157. doi: 10.1136/bmjopen-2021-060157.

Helpful Links

• Link to published study protocol

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: July 17, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: ischemic heart disease; cardiac rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Vascular Diseases; Heart Diseases; Myocardial Ischemia; Cardiovascular Diseases; Ischemia; Heart Arrest
• Other Study ID Numbers: EMN-2021-00020 (Other Identifier: Research Ethics Committee of Region Zealand, Denmark); REG-162-2020 (Other Identifier: Danish Data Protection Agency through Region Zealand)

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