Pulmonary FunctionNCT06876961
Effect of Arm Cycling Exercise on Pulmonary Functions After Colectomy In Elderly
A study testing Arm cycling exercise and The traditional physical therapy program in people with Pulmonary Function and Colectomy, run by Cairo University at 1 site in Bahrain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Pulmonary Function, Colectomy, Colorectal Cancer
- What is being tested?
- Arm cycling exercise and The traditional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBahrain
- Study dates
- 15 Mar 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pulmonary Function, Colectomy, Colorectal Cancer, Post-operative Rehabilitation, Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Arm Cycle Ergometer
- Being tested
- Arm cycling exercise, The traditional physical therapy program
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm cycling exerciseOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm cycling exercise | Experimental | The study group, including 30 participants, will do 20 minutes of arm cycling exercise plus the traditional physical therapy program. Receives: 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 Receives: Other: The traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: at Baseline Day 1 and at the day 5 Postoperative
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.
Measured: At baseline and at the day 5 post-operative
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.
Measured: 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.
Measured: At baseline and at the day 5 post-operative
Secondary outcomes (8)
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)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: At baseline and at the day 5 post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start15 Mar 2025
- Primary completion1 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FunctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Israa Mohammed AbdelMoneim Youssef, Cairo University
- Investigators
- Israa Youssef, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876961
- Sponsor's protocol ID
- Israa-005640
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arm Cycling Exercise on Pulmonary Functions After Colectomy In Elderly
- ClinicalTrials.gov ID
- NCT06876961
- Acronym / sponsor ID
- Israa-005640
- Conditions
- Pulmonary Function, Colectomy, Colorectal Cancer, Post-operative Rehabilitation, Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Arm Cycle Ergometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Prospective Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Arm cycling exercise | Experimental | Other: Arm cycling exercise, Other: The traditional physical therapy programThe study group, including 30 participants, will do 20 minutes of arm cycling exercise plus the traditional physical therapy program. |
| traditional physical therapy | Active comparator | Other: The traditional physical therapy programThe control group, including 30 participants, will do the traditional physical therapy program only |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm cycling exerciseThe 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 | Arm cycling exercise |
| The traditional physical therapy programThe 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. | Other | Arm cycling exercise, traditional physical therapy |
Primary outcome
Assessing the change of forced vital capacity using spirometry
Time frame: At baseline Day 1 and at the day 5 post-operative
It will be conducted noninvasively using a spirometer, measuring: forced vital capacity (FVC) in Litres is known as total exhaled volume.
Assessing the change of forced expiratory volume in 1 second using spirometry
Time frame: At baseline day 1 and at the day 5 post-operative
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.
Assessing The ratio of FEV1 and FVC (FEV1/FVC)
Time frame: at Baseline Day 1 and at the day 5 Postoperative
It is a Pulmonary Function measurement that evaluates the Pulmonary Functions
Assessment of change of diaphragmatic excursion using ultrasonography
Time frame: At baseline and at the day 5 post-operative
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.
Assessment of change of diaphragmatic Function using ultrasonography
Time frame: At baseline and at the day 5 post-operative
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.
Assessment of change of functional capacity
Time frame: At baseline and at the day 5 post-operative
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.
8 secondary outcomes
Assessment of change of potential of partial pressure of oxygen
Time frame: At baseline and at the day 5 post-operative
Assessment of change of partial pressure of carbon dioxide (PaCO₂)
Time frame: At baseline and at the day 5 post-operative
Assessment of change of potential of hydrogen (PH)
Time frame: At baseline and at the day 5 post-operative
Assessment of change of bicarbonate (HCO₃)
Time frame: At baseline and at the day 5 post-operative
Assessment of change of lactate
Time frame: At baseline and at the day 5 post-operative
Assessment of change of physical function in intensive care unit tested scored (PFIT)
Time frame: At baseline and at the day 5 post-operative
Assessment of change of anxiety (HAD scale )
Time frame: At baseline and at the day 5 post-operative
Assessment of change of depression ( HAD scale )
Time frame: At baseline and at the day 5 post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Israa Youssef principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm cycling exercise and The traditional physical therapy program in people with Pulmonary Function and Colectomy, run by Cairo University at 1 site in Bahrain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bahrain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change of forced vital capacity using spirometry (time frame: At baseline Day 1 and at the day 5 post-operative). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.