Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-31 @ 11:32 PM
Study NCT ID:
NCT06876961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-14
First Post:
2025-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Arm Cycling Exercise on Pulmonary Functions After Colectomy In Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the change of forced vital capacity using spirometry', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': 'It will be conducted noninvasively using a spirometer, measuring: forced vital capacity (FVC) in Litres is known as total exhaled volume.'}, {'measure': 'Assessment of change of functional capacity', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': '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.'}, {'measure': 'Assessment of change of diaphragmatic excursion using ultrasonography', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': '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.'}, {'measure': 'Assessment of change of diaphragmatic excursion using ultrasonography', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': '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.'}, {'measure': 'Assessing the change of forced expiratory volume in 1 second using spirometry', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': 'It will be conducted noninvasively using a spirometer, measuring:\n\n2-forced expiratory volume in 1 second (FVC1) in liters is known as volume exhaled in the first second.'}], 'secondaryOutcomes': [{'measure': 'Assessment of change of potential of partial pressure of oxygen', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': '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)'}, {'measure': 'Assessment of change of bicarbonate (HCO₃)', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': '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)'}, {'measure': 'Assessment of change of anxiety', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': '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'}, {'measure': 'Assessment of change of depression', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': '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'}, {'measure': 'Assessment of change of physical function in intensive care unit tested scored (PFIT)', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': '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.\n\nThe 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.'}, {'measure': 'Assessment of change of partial pressure of carbon dioxide (PaCO₂)', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': '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).'}, {'measure': 'Assessment of change of potential of hydrogen (PH)', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': 'Arterial geometry will be used to examine the effect of cycling exercise on gas exchange, including the potential of hydrogen (PH)'}, {'measure': 'Assessment of change of lactate', 'timeFrame': 'At baseline and at the day 5 post-operative', 'description': 'Arterial geometry will be used to examine the effect of cycling exercise on gas exchange, including the lactate millimoles per liter (mmol/L).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Function', 'Colectomy', 'Colorectal Cancer', 'Post-operative Rehabilitation', 'Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)', 'Arm Cycle Ergometer', 'Pulmonary Rehabilitation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'genderBased': True, 'genderDescription': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 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.\n2. Patients with a histologically confirmed diagnosis of primary colon or rectal neoplasm.\n3. Colectomy isolated surgeries.\n4. Patients will be included in this study after the immediate admission to the intensive care unit.\n5. The age of patients will be ≥ 65 years old.\n6. Patients' body mass index will be \\< 30 Kg/m2.\n7. All patients will be conscious, medically stable, and able to respond to the given commands fully.\n8. Patients who voluntarily cooperated with this study\n9. 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\n\nExclusion Criteria:\n\nMen who will meet one of the following criteria will be excluded:\n\n1. relapsing cancer or metastasis cancer; simultaneous diagnosis of other neoplasms.\n2. Cardiac disease patients.\n3. Chronic inflammatory autoimmune disease\n4. Patients with neurological conditions limit the performance of exercises.\n5. Patients with diagnosed psychogenic diseases.\n6. Patients with musculoskeletal disorders that interfere with performing exercise programs.\n7. Chronic obstructive pulmonary disease, Asthma, hemodynamically unstable, significant arrhythmias, and any chronic lung disease.\n8. Patients require invasive/noninvasive ventilatory support.\n9. regular use of immunosuppressive drugs.\n10. Patients with cognitive disorders and unstable hemodynamics.\n11. patients suffering from brain death; or respiratory failure; ventilator-dependent patients: patients receiving palliative care or patients on tracheostomy.\n12. inability to understand given information due to language or intellectual barriers."}, 'identificationModule': {'nctId': 'NCT06876961', 'briefTitle': 'Effect of Arm Cycling Exercise on Pulmonary Functions After Colectomy In Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Arm Cycling Exercise on Pulmonary Functions After Colectomy In Elderly', 'orgStudyIdInfo': {'id': 'Israa-005640'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm cycling exercise', 'description': 'The study group, including 30 participants, will do 20 minutes of arm cycling exercise plus the traditional physical therapy program.', 'interventionNames': ['Other: Arm cycling exercise', 'Other: The traditional physical therapy program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional physical therapy', 'description': 'The control group, including 30 participants, will do the traditional physical therapy program only', 'interventionNames': ['Other: The traditional physical therapy program']}], 'interventions': [{'name': 'Arm cycling exercise', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Arm cycling exercise']}, {'name': 'The traditional physical therapy program', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Arm cycling exercise', 'traditional physical therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Muharraq', 'country': 'Bahrain', 'contacts': [{'name': 'Israa Mohamed Abdelmoneim youssef, physiotherapist', 'role': 'CONTACT', 'email': 'israa.yussif@gmail.com', 'phone': '+201112388838'}], 'facility': 'the intensive care unit of King Hamad University Hospital,', 'geoPoint': {'lat': 26.25722, 'lon': 50.61194}}], 'centralContacts': [{'name': 'Israa Mohamed Abdelmoneim Youssef, physical therapist', 'role': 'CONTACT', 'email': 'israa.yussif@gmail.com', 'phone': '+201112388838'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Israa Mohammed AbdelMoneim Youssef', 'investigatorAffiliation': 'Cairo University'}}}}