Cardiac Rehabilitation and Sedentary Behavior

NCT03200756 | Completed

• 1 other identifier: 15-1914
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This trial randomizes patients who plan to attend cardiac rehabilitation to either a behavioral intervention to specifically reduce sedentary behavior or to usual care which exclusively focuses on increasing exercise.

Conditions

Cardiovascular Diseases

Keywords

sedentary behavior

Outcome Measures

Primary Outcomes (2)

• Change in steps per day from before to after cardiac rehabilitation

  The number of steps per day will be recorded using the Activpal monitor. Investigators will compare the number of steps per day prior to the subject beginning rehabiliation to the number of steps per day after cardiac rehabilitation is complete

  1 full week of Activpal data collected at week1, week 7, week 13, week 17 of the study

• Change in sedentary time from before to after cardiac rehabilitation

  The number of sedentary hours per day will be recorded using the Activpal monitor.Investigators will compare the number of sedentary hours per day recorded prior to the subject beginning cardiac rehabilitation to the number of sedentary hours per day recorded after cardiac rehabilitation is complete

  1 full week of Activpal data collected at week1, week 7, week 13, week 17 of the study

Study Arms (2)

Sedentary Group

EXPERIMENTAL

The experimental group undergoes a behavioral intervention to reduce sedentary behavior which includes a patient centered approach with monitoring and goal setting.

Behavioral: Sedentary Group

Exercise Group

ACTIVE COMPARATOR

The Active Comparative group undergoes a standard clinical approach to increase exercise which is patient centered with monitoring and goal setting.

Behavioral: Exercise Group

Interventions

Sedentary Group BEHAVIORAL

The sedentary group undergoes a behavioral intervention to reduce sedentary behavior which includes a patient centered approach with monitoring and goal setting.

Sedentary Group

Exercise Group BEHAVIORAL

The Active Comparative group undergoes a standard clinical approach to increase exercise which is patient centered with monitoring and goal setting.

Exercise Group

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients enrolled in Cardiac Rehabilitation
• Age 50 years old or greater
• Short Physical Performance Battery (SPPB) score equal or less than 10

You may not qualify if:

• Hypoxia
• Orthopedic Disease that limits mobility
• Neurologic Disease that limits mobility
• Metastatic Cancer
• Life expectancy of \<6 months
• Depression
• Montreal Cognitive Assessment less than 24
• Left Ventricular Assist Device (LVAD)
• Cardiac Transplant
• Patient Health Questionnaire-9 (PHQ-9) of 15 or greater

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital Cardiovascular Rehabilitation

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Boxer Rebecca, MD,MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 27, 2017
• Study Start: June 20, 2017
• Primary Completion: June 20, 2017
• Study Completion: June 20, 2017
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)