Effect of Arm Cycling Exercise on Pulmonary Functions After Colectomy In Elderly

NCT06876961 | Not Yet Recruiting

• 1 other identifier: Israa-005640
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be done to investigate the effect of arm cycling on exercise and functional capacity, arterial blood gases, pulmonary functions, diaphragmatic excursion, time to peak inspiratory amplitude, physical function, anxiety, and depression after colectomy in the elderly.

Conditions

Pulmonary Function; Colectomy; Colorectal Cancer; Post-operative Rehabilitation; Intensive Care Unit (ICU) Acquired Weakness (ICU - AW); Arm Cycle Ergometer; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (5)

• Assessing the change of forced vital capacity using spirometry

  It will be conducted noninvasively using a spirometer, measuring: forced vital capacity (FVC) in Litres is known as total exhaled volume.

  At baseline and at the day 5 post-operative

• Assessment of change of functional capacity

  A 6-minute stepper test is proposed to evaluate exercise tolerance using a standardized protocol. The test measures the number of steps performed on a stepper in 6 minutes, equivalent to the 6-minute walk test. Patients are accustomed to the stepper for 2 minutes, followed by a 3-minute rest and 6-minute stepping period. Heart rate and oxygen saturation are monitored, and an investigator stays behind the patient throughout the test.

  At baseline and at the day 5 post-operative

• Assessment of change of diaphragmatic excursion using ultrasonography

  Participants undergo ultrasonography to measure diaphragmatic excursion In centimeters (cm) . The measurement will be performed using a 1- to 5-MHz ultrasound transducer in M-mode.

  At baseline and at the day 5 post-operative

• Assessment of change of diaphragmatic excursion using ultrasonography

  Participants undergo ultrasonography to measure the Time-to-peak inspiratory amplitude (TPIAdia) of the diaphragm during tidal breathing in seconds (sec) of each hemidaphragm ( right and left ). The measurement will be performed using a 1- to 5-MHz ultrasound transducer in M-mode.

  At baseline and at the day 5 post-operative

• Assessing the change of forced expiratory volume in 1 second using spirometry

  It will be conducted noninvasively using a spirometer, measuring: 2-forced expiratory volume in 1 second (FVC1) in liters is known as volume exhaled in the first second.

  At baseline and at the day 5 post-operative

Secondary Outcomes (8)

• Assessment of change of potential of partial pressure of oxygen

  At baseline and at the day 5 post-operative

• Assessment of change of bicarbonate (HCO₃)

  At baseline and at the day 5 post-operative

• Assessment of change of anxiety

  At baseline and at the day 5 post-operative

• Assessment of change of depression

  At baseline and at the day 5 post-operative

• Assessment of change of physical function in intensive care unit tested scored (PFIT)

  At baseline and at the day 5 post-operative

Study Arms (2)

Arm cycling exercise

EXPERIMENTAL

The study group, including 30 participants, will do 20 minutes of arm cycling exercise plus the traditional physical therapy program.

Other: Arm cycling exercise; Other: The traditional physical therapy program

traditional physical therapy

ACTIVE COMPARATOR

The control group, including 30 participants, will do the traditional physical therapy program only

Other: The traditional physical therapy program

Interventions

Arm cycling exercise OTHER

The study involves a 20-minute arm cycling exercise twice daily for five days, starting with a warming-up and ending with a cooling-down. The workload is gradually increased to 60-70% of maximal heart rate, with patients sitting on a back support chair with 20 degrees backward inclination.

Arm cycling exercise

The traditional physical therapy program OTHER

The patient undergoes 10 minutes of deep diaphragmatic breathing exercises, 10 minutes of spirometer training, 3-set ankle pump and heel slide exercises, 10-minute sitting on the bed edge, 5 minutes of walking in the intensive care unit, and 3-set active free range of motion exercises.

Arm cycling exercise; traditional physical therapy

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Sixty male patients who received a surgical removal of a diagnosed colon cancer (i.e., including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy) will be included.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Sixty male patients who received a surgical removal of a diagnosed colon cancer (i.e., including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy) will be included.
• Patients with a histologically confirmed diagnosis of primary colon or rectal neoplasm.
• Colectomy isolated surgeries.
• Patients will be included in this study after the immediate admission to the intensive care unit.
• The age of patients will be ≥ 65 years old.
• Patients' body mass index will be \< 30 Kg/m2.
• All patients will be conscious, medically stable, and able to respond to the given commands fully.
• Patients who voluntarily cooperated with this study
• Karnofsky Performance Status \> 60 and able to walk ≥ 60 m. The Karnosky Performance Status is one of the most used validated scales to define the functional status of a cancer patient. A Karnofsky Performance Status ≤ 60 indicates the inability to work and severe difficulty in carrying out activities of daily living and personal care of the cancer patient Before surgeries

You may not qualify if:

• Men who will meet one of the following criteria will be excluded:
• relapsing cancer or metastasis cancer; simultaneous diagnosis of other neoplasms.
• Cardiac disease patients.
• Chronic inflammatory autoimmune disease
• Patients with neurological conditions limit the performance of exercises.
• Patients with diagnosed psychogenic diseases.
• Patients with musculoskeletal disorders that interfere with performing exercise programs.
• Chronic obstructive pulmonary disease, Asthma, hemodynamically unstable, significant arrhythmias, and any chronic lung disease.
• Patients require invasive/noninvasive ventilatory support.
• regular use of immunosuppressive drugs.
• Patients with cognitive disorders and unstable hemodynamics.
• patients suffering from brain death; or respiratory failure; ventilator-dependent patients: patients receiving palliative care or patients on tracheostomy.
• inability to understand given information due to language or intellectual barriers.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

the intensive care unit of King Hamad University Hospital,

Al Muharraq, Bahrain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Israa Mohamed Abdelmoneim Youssef, physical therapist

CONTACT

+201112388838; israa.yussif@gmail.com

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: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 14, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

BA (1)