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

NCT ID: NCT06876961

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm cycling exercise

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

Group Type EXPERIMENTAL

Arm cycling exercise

Intervention Type 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.

The traditional physical therapy program

Intervention Type 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.

traditional physical therapy

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

Group Type ACTIVE_COMPARATOR

The traditional physical therapy program

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Israa Mohammed AbdelMoneim Youssef

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the intensive care unit of King Hamad University Hospital,

Al Muharraq, , Bahrain

Site Status

Countries

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Bahrain

Central Contacts

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Israa Mohamed Abdelmoneim Youssef, physical therapist

Role: CONTACT

+201112388838

Facility Contacts

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Israa Mohamed Abdelmoneim youssef, physiotherapist

Role: primary

+201112388838

Other Identifiers

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Israa-005640

Identifier Type: -

Identifier Source: org_study_id

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