Maintenance of Physical Activity After Cardiac Rehabilitation

NCT05011994 | Unknown

• 2 other identifiers: EMN-2021-00020REG-162-2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Heart Failure; Arrythmia; Heart Arrest

Keywords

cardiac rehabilitation; ischemic heart disease

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• Physical activity, objectively measured

  Change from baseline to 12 weeks

• Physical function, walking

  Change from baseline to 12 weeks

• Physical function, sit-to-stand

  Change from baseline to 12 weeks

• Physical activity, subjectively measured

  Change from baseline to 12 weeks

Other Outcomes (10)

• Health-related quality of life, general

  Change from baseline to 12 weeks

• Health-related quality of life, VAS subscale

  Change from baseline to 12 weeks

• Health-related quality of life, heart-specific

  Change from baseline to 12 weeks

Study Arms (1)

Maintenance intervention

EXPERIMENTAL

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

Behavioral: Maintenance intervention

Interventions

Maintenance intervention BEHAVIORAL

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

Maintenance intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Slagelse Hospital: lead
• City of Slagelse (municipality): collaborator
• Holbaek Sygehus: collaborator
• University of Southern Denmark: collaborator
• University College Copenhagen: collaborator

Study Sites (3)

Holbæk Hospital

Holbæk, 4300, Denmark

RECRUITING

City of Slagelse (municipality)

Korsør, 4220, Denmark

RECRUITING

Slagelse Hospital

Slagelse, 4200, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 35383088 DERIVED

Related Links

• Link to published study protocol

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Heart Failure; Arrhythmias, Cardiac; Heart Arrest

Condition Hierarchy (Ancestors)

Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rune M Andersen, PhD

  Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Rune M Andersen, PhD

CONTACT

+4529623522; ruma@regionsjaelland.dk

Lars H Tang, PhD

CONTACT

+4558559790; larta@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2021
• First Posted: August 19, 2021
• Study Start: August 30, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)