Effects of a Multidimensional Exercise Program on Cardiac Surgery Patients

NCT ID: NCT04332887

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-02

Study Completion Date

2021-03-11

Brief Summary

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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.

Detailed Description

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This study aims to develop a multidimensional exercise program and examine the effects of an exercise program on cardiac surgery patients. An experimental design is used. Subjects are recruited using convenience sampling and randomly assigned to the intervention or control group using the block randomization method. Patients in the intervention group will receive a 12-week multidimensional exercise program, including individual nursing consultation, an exercise program that includes moderate intensity walking for 30-45 minutes per day, three days per week combined resistance exercise, nutrition assessment, and instructions, and support. 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. The data were analyzed using SPSS version 22.0, and data analysis methods include descriptive statistics, independent t-test, chi-square, and generalized estimating equation.

Conditions

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Cardiac Surgery Frailty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
One research assistant is trained for being a outcomes assessor in this study who did not know the allocation of participants.

Study Groups

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Multidimensional Exercise Program

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.

Group Type EXPERIMENTAL

Multidimensional Exercise Program

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multidimensional Exercise Program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. aged above 40 years old and received cardiac surgery via median sternotomy with a stable physical condition;
2. 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);
3. had clear consciousness (Mini-Mental State Examination score\>24) and can communicate with Mandarin or Taiwanese;
4. consent to participate in this study.

Exclusion Criteria

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

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Ai-Fu Chiou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ai-Fu Chiou, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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National Yang Ming Chiao Tung University

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 11253156 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21744061 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28285121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29073924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21878207 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39825783 (View on PubMed)

Other Identifiers

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YM105127F-2

Identifier Type: -

Identifier Source: org_study_id

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