Clinical trial NCT06876961: Effect of Arm Cycling Exercise on Pulmonary Functions After Colectomy In Elderly
Official title: Effect of Arm Cycling Exercise on Pulmonary Functions After Colectomy In Elderly
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Function
Colectomy
Colorectal Cancer
Post-operative Rehabilitation
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)
Arm Cycle Ergometer
Pulmonary Rehabilitation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 60
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessing the change of forced vital capacity using spirometry
timeFrame: At baseline and at the day 5 post-operative
measure: Assessment of change of functional capacity
timeFrame: At baseline and at the day 5 post-operative
measure: Assessment of change of diaphragmatic excursion using ultrasonography
timeFrame: At baseline and at the day 5 post-operative
measure: Assessment of change of diaphragmatic excursion using ultrasonography
timeFrame: At baseline and at the day 5 post-operative
measure: Assessing the change of forced expiratory volume in 1 second using spirometry
timeFrame: At baseline and at the day 5 post-operative
Secondary outcomes:
measure: Assessment of change of potential of partial pressure of oxygen
timeFrame: At baseline and at the day 5 post-operative
measure: Assessment of change of bicarbonate (HCO₃)
timeFrame: At baseline and at the day 5 post-operative
measure: Assessment of change of anxiety
timeFrame: At baseline and at the day 5 post-operative
measure: Assessment of change of depression
timeFrame: At baseline and at the day 5 post-operative
measure: Assessment of change of physical function in intensive care unit tested scored (PFIT)
timeFrame: At baseline and at the day 5 post-operative
measure: Assessment of change of partial pressure of carbon dioxide (PaCO₂)
timeFrame: At baseline and at the day 5 post-operative
measure: Assessment of change of potential of hydrogen (PH)
timeFrame: At baseline and at the day 5 post-operative
measure: Assessment of change of lactate
timeFrame: At baseline and at the day 5 post-operative
Other outcomes:
Locations:
city: Muharraq
country: Bahrain
facility: the intensive care unit of King Hamad University Hospital,
Study officials:
References: