Cardiovascular DiseasesFAIRNCT05011994
Maintenance of Physical Activity After Cardiac Rehabilitation
A study testing Maintenance intervention in people with Cardiovascular Diseases and Heart Diseases, run by Slagelse Hospital at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia
- What is being tested?
- Maintenance intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesDenmark
- Study dates
- 30 Aug 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites, 3 recruiting
- Recruiting
Holbæk Hospital
Holbæk, 4300
- Recruiting
City of Slagelse (municipality)
Korsør, 4220
- Recruiting
Slagelse Hospital
Slagelse, 4200
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Heart Failure, Arrythmia, Heart Arrest
- Being tested
- Maintenance intervention
- Keywords
- cardiac rehabilitation, ischemic heart disease
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Heart Failure, Arrhythmias, Cardiac, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Maintenance intervention | Experimental | Participants will receive a 12-week mobile health (mHealth) intervention that consists of action planning, text messages, and coordinator support. Receives: Behavioral: Maintenance intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Secondary outcomes (4)
Physical activity, objectively measured
Measured with thigh and wrist accelerometers
Measured: Change from baseline to 12 weeks
Physical function, walking
6 minute walking test
Measured: Change from baseline to 12 weeks
Physical function, sit-to-stand
30-second sit-to-stand test
Measured: 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).
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start30 Aug 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slagelse Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- City of Slagelse (municipality), Holbaek Sygehus, University of Southern Denmark, University College Copenhagen
- Responsible party
- Sponsor
- Investigators
- Rune M Andersen, PhD, Principal investigator, Næstved-Slagelse-Ringsted Hospitals; University of Southern DenmarkLars H Tang, PhD, Study chair, Næstved-Slagelse-Ringsted Hospitals; University of Southern DenmarkSøren T Skou, PhD, Study chair, Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011994
- Sponsor's protocol ID
- EMN-2021-00020
- Other IDs
- EMN-2021-00020, REG-162-2020
- Acronym
- FAIR
- Status last verified
- Apr 2022
- First submitted
- 17 Jul 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35383088
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Physical Activity After Cardiac Rehabilitation: a Feasibility Trial
- ClinicalTrials.gov ID
- NCT05011994
- Acronym / sponsor ID
- FAIR / EMN-2021-00020
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Heart Failure, Arrythmia, Heart Arrest
- Keywords
- cardiac rehabilitation, ischemic heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Slagelse HospitalUniversity, hospital or other
- Collaborators
- City of Slagelse (municipality), Holbaek Sygehus, University of Southern Denmark, University College Copenhagen
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance intervention | Experimental | Behavioral: Maintenance interventionParticipants will receive a 12-week mobile health (mHealth) intervention that consists of action planning, text messages, and coordinator support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintenance interventionThe 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 | Behavioural | Maintenance intervention |
Primary outcome
Recruitment
Time frame: 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
Attrition/retention through follow-up assessment session
Time frame: 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
Time frame: Baseline
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
Accelerometer data completeness
Time frame: 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
Response rate on patient reported outcomes
Time frame: Baseline
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 on patient reported outcomes
Time frame: 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
Coordinator time spent, minutes per participant throughout the intervention
Time frame: 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
Response rate (adherence) to weekly follow-up messages
Time frame: 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
Acceptability of text message component, single item
Time frame: 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
4 secondary outcomes
Physical activity, objectively measured
Time frame: Change from baseline to 12 weeks
Physical function, walking
Time frame: Change from baseline to 12 weeks
Physical function, sit-to-stand
Time frame: Change from baseline to 12 weeks
Physical activity, subjectively measured
Time frame: Change from baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Derived from this study: PubMed 35383088Andersen 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.
- Link to published study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rune M Andersen, PhD principal investigator
Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Lars H Tang, PhD study chair
Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Søren T Skou, PhD study chair
Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maintenance intervention in people with Cardiovascular Diseases and Heart Diseases, run by Slagelse Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rune M Andersen, PhD (+4529623522 ext. +4558559790, ruma@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05011994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.