NCT05936879

Brief Summary

Patient in the Intervention group will be treated with routine pysical therapy, Inspiratory muscle training and early ambulation after surgery, whereas patients in the control group will be not be treated with these interventions and will rather undergo routine physical therapy (ankle pumps, hand pumps isometrics of upper and lower limbs). Patients in the intervention group will receive treatment until discharge from hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 14, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 14, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

functional capacitylung capacityrehabilitation

Outcome Measures

Primary Outcomes (1)

  • 6 Min walk test

    The 6 min walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance.It is also use to monitor your response to treatments for heart lung and other health problems.Provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

    4 weeks

Secondary Outcomes (1)

  • Spirometer:

    4 weeks

Study Arms (2)

Inspiratory muscle training and early ambulation

EXPERIMENTAL

Intervention group will be treated with Inspiratory muscle training once in a week for at least 3 weeks

Other: Inspiratory muscle training

physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs.

EXPERIMENTAL

Control group routine physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs once in a week for at least 3 weeks

Other: physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs.

Interventions

Group A: Intervention group will be treated with Inspiratory muscle training and early ambulation and routine physical therapy including ankle pumps,hand pumps isometrics of upper and lower limbs after surgery

Inspiratory muscle training and early ambulation

Group B: Control group routine physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs

physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs.

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both Gender patients
  • Patients who agreed to participate
  • Age: 35 to 55

You may not qualify if:

  • Patients with history of Angioplasty or CABG
  • Chronic Renal failure
  • Cardiac arrhythmias
  • History of stroke
  • Unstable angina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National hospital Lahore.

Lahore, Punjab Province, Pakistan

Location

Related Publications (4)

  • Pinheiro AR, Christofoletti G. Motor physical therapy in hospitalized patients in an intensive care unit: a systematic review. Rev Bras Ter Intensiva. 2012 Jun;24(2):188-96. English, Portuguese.

    PMID: 23917769BACKGROUND
  • Shakouri SK, Salekzamani Y, Taghizadieh A, Sabbagh-Jadid H, Soleymani J, Sahebi L, Sahebi R. Effect of respiratory rehabilitation before open cardiac surgery on respiratory function: a randomized clinical trial. J Cardiovasc Thorac Res. 2015;7(1):13-7. doi: 10.15171/jcvtr.2015.03. Epub 2015 Mar 29.

    PMID: 25859310BACKGROUND
  • Oliveira EK, Silva VZ, Turquetto AL. Relationship on walk test and pulmonary function tests with the length of hospitalization in cardiac surgery patients. Rev Bras Cir Cardiovasc. 2009 Oct-Dec;24(4):478-84. doi: 10.1590/s0102-76382009000500008. English, Portuguese.

    PMID: 20305920BACKGROUND
  • Caso G, Vosswinkel JA, Garlick PJ, Barry MK, Bilfinger TV, McNurlan MA. Altered protein metabolism following coronary artery bypass graft (CABG) surgery. Clin Sci (Lond). 2008 Feb;114(4):339-46. doi: 10.1042/CS20070278.

    PMID: 17953516BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sidra Faisal, MS.CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A randomized control trial in which two groups one is intervention and the other is controlled group .Patient in the Intervention group will be treated with routine pysical therapy, Inspiratory muscle training and early ambulation after surgery, whereas patients in the control group will be not be treated with these interventions and will rather undergo routine physical therapy (ankle pumps, hand pumps isometrics of upper and lower limbs). Patients in the intervention group will receive treatment until discharge from hospital.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized control trial in which two groups one is intervention and the other is controlled group .Patient in the Intervention group will be treated with routine pysical therapy, Inspiratory muscle training and early ambulation after surgery, whereas patients in the control group will be not be treated with these interventions and will rather undergo routine physical therapy (ankle pumps, hand pumps isometrics of upper and lower limbs). Patients in the intervention group will receive treatment until discharge from hospital.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 10, 2023

Study Start

June 15, 2023

Primary Completion

August 15, 2023

Study Completion

November 20, 2023

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations