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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Pulmonary Rehabilitation; Pulmonary Function; Colectomy; Intensive Care Unit (ICU) Acquired Weakness (ICU - AW); Post-operative Rehabilitation; Arm Cycle Ergometer
• Intervention / Treatment: Other: Arm cycling exercise; Other: The traditional physical therapy program

Detailed Description

Around 42% of older patients with Chronic Respiratory Disease are considered 'frail', putting them at higher risk of adverse outcomes after surgery. Factors such as poor frailty, high comorbidity, low physical performance, poor nutritional state, or cognitive impairment increase the risk. Postoperative complications, such as pulmonary complications, can lead to increased morbidity, mortality, and hospital stays. Preoperative physiotherapy and exercise interventions have been suggested as preventive solutions. However, many patients undergo emergency surgery, emphasizing the need for strict postoperative care pathways. Exercise interventions, such as upper extremity aerobic exercise, have shown benefits in improving immobilization, oxygen consumption, ventilation, heart rate response, dyspnea, and quality of life. This study aims to investigate the effects of arm cycling on exercise capacity, arterial blood gases, pulmonary functions, diaphragmatic excursion, anxiety, and depression after colectomy in the elderly.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bahrain
  • Al Muharraq, Bahrain
    • King Hamad University Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Patients with a histologically confirmed diagnosis of primary colon or rectal neoplasm.
3. Colectomy isolated surgeries.
4. Patients will be included in this study after the immediate admission to the intensive care unit.
5. The age of patients will be ≥ 65 years old.
6. Patients' body mass index will be < 30 Kg/m2.
7. All patients will be conscious, medically stable, and able to respond to the given commands fully.
8. Patients who voluntarily cooperated with this study
9. 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

Exclusion Criteria:

Men who will meet one of the following criteria will be excluded:

1. relapsing cancer or metastasis cancer; simultaneous diagnosis of other neoplasms.
2. Cardiac disease patients.
3. Chronic inflammatory autoimmune disease
4. Patients with neurological conditions limit the performance of exercises.
5. Patients with diagnosed psychogenic diseases.
6. Patients with musculoskeletal disorders that interfere with performing exercise programs.
7. Chronic obstructive pulmonary disease, Asthma, hemodynamically unstable, significant arrhythmias, and any chronic lung disease.
8. Patients require invasive/noninvasive ventilatory support.
9. regular use of immunosuppressive drugs.
10. Patients with cognitive disorders and unstable hemodynamics.
11. patients suffering from brain death; or respiratory failure; ventilator-dependent patients: patients receiving palliative care or patients on tracheostomy.
12. inability to understand given information due to language or intellectual barriers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm cycling exercise; The study group, including 30 participants, will do 20 minutes of arm cycling exercise plus the traditional physical therapy program.	Other: Arm cycling exercise; 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.; Other: The traditional physical therapy program; 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.
Active Comparator: traditional physical therapy; The control group, including 30 participants, will do the traditional physical therapy program only	Other: The traditional physical therapy program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Day 1 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: forced expiratory volume in 1 second (FEV1) in liters is known as volume exhaled in the first second.	At baseline day 1 and at the day 5 post-operative
Assessing The ratio of FEV1 and FVC (FEV1/FVC)	It is a Pulmonary Function measurement that evaluates the Pulmonary Functions	at Baseline Day 1 and at the day 5 Postoperative
Assessment of change of diaphragmatic Function 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change of potential of partial pressure of oxygen	Arterial geometry will be used to examine the effect of cycling exercise on gas exchange, including the potential of partial pressure of oxygen (PaO₂) in millimeters of mercury (mmHg)	At baseline and at the day 5 post-operative
Assessment of change of bicarbonate (HCO₃)	Arterial geometry will be used to examine the effect of cycling exercise on gas exchange, including the bicarbonate (HCO₃) in millimoles per liter (mmol/L)	At baseline and at the day 5 post-operative
Assessment of change of physical function in intensive care unit tested scored (PFIT)	Physical function in intensive care test score (PFIT)-s will be used to assess physical function, consisting of four components: 1-assistance, 2-marching, 3-shoulder flexion strength, and 4-knee extension strength. The strength was based on the Oxford grading system, with each component mentioned above scoring 0-3 and summed to a maximum ordinal score of 12 points, Ranging from 0-12 with a higher score reflecting a better physical function.	At baseline and at the day 5 post-operative
Assessment of change of partial pressure of carbon dioxide (PaCO₂)	Arterial geometry will be used to examine the effect of cycling exercise on gas exchange, including the partial pressure of carbon dioxide (PaCO₂) in millimeters of mercury (mmHg).	At baseline and at the day 5 post-operative
Assessment of change of potential of hydrogen (PH)	Arterial geometry will be used to examine the effect of cycling exercise on gas exchange, including the potential of hydrogen (PH)	At baseline and at the day 5 post-operative
Assessment of change of lactate	Arterial geometry will be used to examine the effect of cycling exercise on gas exchange, including the lactate millimoles per liter (mmol/L).	At baseline and at the day 5 post-operative
Assessment of change of anxiety (HAD scale )	The Hospital Anxiety and Depression Scale will be used. it is a 14-item self-report screening scale with 7 items each for anxiety. A score of 0-7 is considered normal; 8-10 indicates mild illness, 11-15 moderate illness, and scores 16-21 are suggestive of severe illness	At baseline and at the day 5 post-operative
Assessment of change of depression ( HAD scale )	The Hospital Anxiety and Depression Scale will be used. it is a 14-item self-report screening scale with 7 items each for depression. A score of 0-7 is considered normal; 8-10 indicates mild illness, 11-15 moderate illness, and scores 16-21 are suggestive of severe illness	At baseline and at the day 5 post-operative

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Israa Youssef, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 15, 2026

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Israa-005640

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No