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

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06876961
Israa-005640

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Male

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Israa Mohamed Abdelmoneim Youssef, physical therapist

Data sourced from clinicaltrials.gov

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