Effects of a Multidimensional Exercise Program on Cardiac Surgery Patients

NCT04332887 | Completed

• 1 other identifier: YM105127F-2
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial study aims to examine the effects of a multidimensional exercise program in cardiac surgery patients. The following hypotheses were tested: patients who received the exercise program will report significant improvement in frailty after the 12-week multidimensional exercise program. Subjects are randomly assigned to the intervention or control group. Patients in the intervention group will receive a 12-week multidimensional exercise program. Data are collected by using medical records and structural questionnaires, measuring handgrip strength, and a four-meter walk test at baseline, 6 weeks, and 12 weeks.

Conditions

Cardiac Surgery; Frailty

Keywords

Cardiac surgery; Frailty; Exercise program; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Changes in Fried's Phenotype of Frailty Status and Frailty Criteria

  Changes from baseline Fried's Phenotype of Frailty include five criteria: weight loss, exhaustion, weakness, slowness, and low physical activity at baseline, 6 weeks, and 12 weeks. Each criteria was identified as positive and negative. Frail was defined if more than two criteria were positive. Pre-frail was defined if one criteria was positive.

  baseline, 6week, 12 week

Study Arms (2)

Multidimensional Exercise Program

EXPERIMENTAL

Patients in the intervention group received a 12-week multidimensional exercise programme that consisted of individual nursing consultation, an exercise program that included moderate intensity walking for 30-45 minutes per day, three days per week and combined resistance exercise, nutrition assessment and instructions, and support.

Behavioral: Multidimensional Exercise Program

Control group

NO INTERVENTION

Patients in this group maintain their daily life activities, and there is no intervention given.

Interventions

Multidimensional Exercise Program BEHAVIORAL

Patients in the experimental group will receive a 12-week multidimensional exercise program; patients in the control group will maintain their usual life activities.

Multidimensional Exercise Program

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged above 40 years old and received cardiac surgery via median sternotomy with a stable physical condition;
• at least met one of the frailty phenotypes, including unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity proposed by Fried et al. (2001);
• had clear consciousness (Mini-Mental State Examination score\>24) and can communicate with Mandarin or Taiwanese;
• consent to participate in this study.

You may not qualify if:

• bed-ridden, cannot stand or depends on others to complete all activities of daily living;
• received emergency cardiac surgery;
• with a mental illness history;
• had exercise contraindications including: in infectious or acute phases, uncontrolled hypertension, arrhythmia, or diabetes mellitus;
• had a musculoskeletal disease, which might be aggravated by exercise;
• participate in phase two of cardiac rehabilitation.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

Related Publications (6)

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Molino-Lova R, Pasquini G, Vannetti F, Paperini A, Forconi T, Polcaro P, Zipoli R, Cecchi F, Macchi C. Effects of a structured physical activity intervention on measures of physical performance in frail elderly patients after cardiac rehabilitation: a pilot study with 1-year follow-up. Intern Emerg Med. 2013 Oct;8(7):581-9. doi: 10.1007/s11739-011-0654-z. Epub 2011 Jul 9.

  PMID: 21744061 BACKGROUND

• Reeves GR, Whellan DJ, O'Connor CM, Duncan P, Eggebeen JD, Morgan TM, Hewston LA, Pastva A, Patel MJ, Kitzman DW. A Novel Rehabilitation Intervention for Older Patients With Acute Decompensated Heart Failure: The REHAB-HF Pilot Study. JACC Heart Fail. 2017 May;5(5):359-366. doi: 10.1016/j.jchf.2016.12.019. Epub 2017 Mar 8.

  PMID: 28285121 BACKGROUND

• Waite I, Deshpande R, Baghai M, Massey T, Wendler O, Greenwood S. Home-based preoperative rehabilitation (prehab) to improve physical function and reduce hospital length of stay for frail patients undergoing coronary artery bypass graft and valve surgery. J Cardiothorac Surg. 2017 Oct 26;12(1):91. doi: 10.1186/s13019-017-0655-8.

  PMID: 29073924 BACKGROUND

• Gary RA, Cress ME, Higgins MK, Smith AL, Dunbar SB. Combined aerobic and resistance exercise program improves task performance in patients with heart failure. Arch Phys Med Rehabil. 2011 Sep;92(9):1371-81. doi: 10.1016/j.apmr.2011.02.022.

  PMID: 21878207 BACKGROUND

• Huang WT, Liu CY, Shih CC, Chen YS, Chou CL, Lee JT, Chiou AF. Effects of a home-based multicomponent exercise programme on frailty in post-cardiac surgery patients: a randomized controlled trial. Eur J Cardiovasc Nurs. 2025 May 28;24(4):580-592. doi: 10.1093/eurjcn/zvaf014.

  PMID: 39825783 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ai-Fu Chiou, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: One research assistant is trained for being a outcomes assessor in this study who did not know the allocation of participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients in the intervention group will receive a 12-week exercise program including individual nursing consultation, exercise program, nutrition assessment and instructions, and support.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: June 2, 2019
• Primary Completion: March 11, 2021
• Study Completion: March 11, 2021
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)