NCT06360146

Brief Summary

Heart and blood vessel problems together referred to as cardiovascular diseases (CVD) include congenital heart disease, cerebrovascular illness, and coronary heart disease. Following heart surgery, patients who are active in the postoperative phase stay in the hospital for shorter periods of time and experience fewer complications. After cardiac surgery, older adults who exercise during the recovery period experience fewer difficulties and hospitalizations. A total of 100 elderly patients-69 men and 31 women-who had undergone cardiac surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B). Older patients undergoing cardiac surgery also experienced improved balance as a result of early mobilization and functional exercises.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 7, 2024

Last Update Submit

April 7, 2024

Conditions

Keywords

early rehabilitationgeriatricscardiac surgery

Outcome Measures

Primary Outcomes (1)

  • International Physical Activity Questionnaire

    The Short Form of the International Physical Activity Questionnaire (SF-IPAQ) was used to measure physical activity (PA). Participants were asked to describe how many days they had spent performing vigorous, moderate, and walking activities over the course of the previous week, as well as the duration of those activities

    0-7 days

Secondary Outcomes (1)

  • Two Minute Walking Test

    0-7 days

Study Arms (2)

Group 1

EXPERIMENTAL

The patients in early mobilization group underwent early mobilization and functional exercises program, while the patients served as the control group did not receive the therapy protocol applied in the early mobilization group

Other: Early mobilisation

Group 2

ACTIVE COMPARATOR

The patients in early mobilization group underwent early mobilization and functional exercises program, while the patients served as the control group did not receive the therapy protocol applied in the early mobilization group

Other: Early mobilisation

Interventions

Breathing exercises, inspiratory muscle strength, postural drainage, functional exercise (stand up and sitting down on the chair, walking inward, back-ward ,and sideways), weight shifts from left to right, step up inside the patch , one leg stand, squatting leaning against wall) for three times per the day and repetition fifteen times (3 times per day for 15 repetition) and supervised walking with increments of 2 minutes, as tolerated up to 6 minutes or more at the morning, afternoon, evening and at night.

Group 1Group 2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Individuals who had previously had valve replacement procedures or coronary artery bypass grafting (CABG) and if all of these procedures were done by sternotomy were included in the study. The study's patients were all classified as geriatric, with ages ranging from 65 to 75. There were people of both genders in the sample. Throughout their recovery, patients who were awake, conscious, and able to communicate vocally as well as those who were able to understand and complete scales and questionnaires. Patients who signed consent forms voluntarily agreed to participate, as well as those who successfully passed the two-minute walk test (2MWT), which assesses how long it takes to walk for two minutes.

You may not qualify if:

  • Patients unable to complete the two-minute walk test (2MWT), scales, or questionnaires. Individuals who suffered from stroke, extensive bleeding, renal failure or insufficiency, atrial fibrillation, the necessity for a second operation, or a serious infection of the sternal wound following surgery. Those who struggle with vocal and auditory communication. individuals who underwent surgery and had a pacemaker inserted. those who have experienced a prior cerebrovascular accident. Those who have suffered from neurological disorders like hemiplegia after heart surgery and mental health problems like intellectual incapacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İsmail Ceylan

Kırşehir, Merkez, 40100, Turkey (Türkiye)

Location

Related Publications (1)

  • Khadanga S, Savage PD, Ades PA. Resistance Training for Older Adults in Cardiac Rehabilitation. Clin Geriatr Med. 2019 Nov;35(4):459-468. doi: 10.1016/j.cger.2019.07.005. Epub 2019 Jul 3.

    PMID: 31543178BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Single
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of hand therapy clinic. PhD.

Study Record Dates

First Submitted

April 7, 2024

First Posted

April 11, 2024

Study Start

April 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations