Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-30 @ 5:49 PM
Study NCT ID:
NCT04892368
Status:
UNKNOWN
Last Update Posted:
2021-06-02
First Post:
2021-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Preoperative Prehabilitation With a Home-based Supervised Exercise Program Against an Unsupervised Exercise Program for Frail Elderly Patients Undergoing Major Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-30', 'studyFirstSubmitDate': '2021-05-04', 'studyFirstSubmitQcDate': '2021-05-13', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in functional walking capacity from baseline to just before surgery, as measured using the 6-minute walk distance.', 'timeFrame': 'From recruitment to 2-days before surgery', 'description': 'Distance that the patient can walk in 6 min, along a 15-20m hallway, at a pace that the participants will be tired at the end of the distance. This is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.'}], 'secondaryOutcomes': [{'measure': '30-day in-hospital complications', 'timeFrame': 'From day of surgery to 30-days afterwards', 'description': 'Classified using the Clavien Dindo Classification'}, {'measure': 'Hospital length-of-stay', 'timeFrame': 'From day of surgery until discharge, or up to 6 months after surgery, whichever occurs first', 'description': 'Duration that patient stayed in hospital from day of surgery to discharge either to home or step-down care'}, {'measure': 'Health-related quality of life outcomes (HRQoL) as measured using the 12-Item Short Form Survey (SF-12)', 'timeFrame': 'Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative', 'description': "SF-12 is a 12-item questionnaire that assesses generic health outcomes from the patient's perspective, and covers eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional \\& mental health."}, {'measure': 'Health-related quality of life outcomes (HRQoL) as measured using the EQ-5D-3L', 'timeFrame': 'Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative', 'description': 'The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.'}, {'measure': 'Change in 6-minute walking distance', 'timeFrame': 'Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative', 'description': 'Distance that the patient can walk in 6 min, along a 15-20m hallway, at a pace that the participants will be tired at the end of the distance. This is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.'}, {'measure': 'Maximal Inspiratory Pressure (MIP)', 'timeFrame': 'Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative', 'description': 'The maximal inspiratory pressure reflects the strength of inspiratory muscles.'}, {'measure': '30-second and 1-minute Sit-to-Stands (STS)', 'timeFrame': 'Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative', 'description': 'The Sit to Stand test reflects lower-extremity strength and endurance.'}, {'measure': 'Handgrip strength (HGS)', 'timeFrame': 'Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative', 'description': "The handgrip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It reflects upper body strength and overall strength."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prehabilitation'], 'conditions': ['Frail Elderly Syndrome', 'Frailty', 'Surgery']}, 'descriptionModule': {'briefSummary': "Singapore's population is ageing, and more elderly people are undergoing elective major surgeries. Frail elderly experience greater functional decline and slower recovery in physical function after surgery compared to non-frail elderly. Preoperative prehabilitation aims to enhance both aerobic capacity and physical strength of elderly to attenuate the post-operative decline in physical function. Singapore General Hospital has a bespoke preoperative program - Prehabilitation for Elderly Frail Patients Undergoing Elective Surgeries (PREPARE), where patients receive physiotherapy education and instructions for home-based unsupervised exercise program (uSEP). A hospital-based supervised exercise program had also been established but the take-up rate was low (7.6%) due to barriers such as cost and accessibility. Perioperative supervised exercise training can effect greater gains in functional capacity and muscle strength compared to no supervision. For the elderly with limited transport options to the hospital, home-based supervised programmes may be more convenient compared to hospital-based supervised programmes, but the former is costlier too. Home-interventions may also empower patients with the skills and confidence to maintain their physical fitness at home, which increases their likelihood of exercising after surgery.\n\nThe investigators propose a prospective single-center randomized controlled trial to evaluate the efficacy of preoperative prehabilitation with a home-based supervised exercise program (SEP) for frail elderly patients undergoing major abdominal surgery, compared to the mainstay of clinical practice, which is a home-based uSEP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Elective major abdominal surgery\n* 2\\. Lead time \\>= 14 days to surgery\n* 3\\. Edmonton Frail Scale total score \\>= 6 points or Functional performance score (Timed up and Go(TUG)) \\>= 1 point\n\nExclusion Criteria:\n\n* 1\\. Inability to provide written informed consent due to cognitive impairment\n* 2\\. Having Comorbid medical conditions interfering with the ability to perform exercise at home or to complete the testing procedures. These include: i. Unstable cardiac conditions ii. Acute illnesses iii. Patients who are completely unable to walk'}, 'identificationModule': {'nctId': 'NCT04892368', 'acronym': 'HOME-PREPARE', 'briefTitle': 'Efficacy of Preoperative Prehabilitation With a Home-based Supervised Exercise Program Against an Unsupervised Exercise Program for Frail Elderly Patients Undergoing Major Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'Prospective Single-centre Randomized Controlled Trial to Evaluate Preoperative Home-based Supervised Exercise Program for Prehabilitation of Frail Elderly Patients Undergoing Major Abdominal Surgery, Against Current Home-based Unsupervised Exercise Program.', 'orgStudyIdInfo': {'id': 'H-PREPARE-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Home supervised exercise program', 'description': 'This group receives standard preoperative physiotherapy education as well a home-exercise instructions. They will also receive 3-4 home visits by physiotherapists between recruitment and surgery, to conduct exercises in their homes.', 'interventionNames': ['Other: Home-based supervised exercise program']}, {'type': 'NO_INTERVENTION', 'label': 'Home unsupervised exercise program', 'description': 'This group receives standard preoperative physiotherapy education as well a home-exercise instructions.'}], 'interventions': [{'name': 'Home-based supervised exercise program', 'type': 'OTHER', 'description': 'Combination of aerobic and strength training exercises, in addition to home exercise instructions issued during preoperative physiotherapy education.', 'armGroupLabels': ['Home supervised exercise program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169608', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Eileen Y Sim', 'role': 'CONTACT', 'email': 'eileen.sim.y.l@singhealth.com.sg', 'phone': '93804422'}, {'name': 'Hairil Rizal Abdullah, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eileen Sim, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chun Ju Tan, Msc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kwong Wei Emile John Tan, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Meihuan Chang, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jia Lin Ng, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ee-Lin Toh, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chung Yip Chang, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hwee Kuan Ong, DClinPT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eleanor Shuxian Chew, Msc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thiri Naing Thin, BN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pei Yi Brenda Tan, BSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Eileen Yilin Sim', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Eileen Y Sim', 'role': 'CONTACT', 'email': 'eileen.sim.y.l@singhealth.com.sg', 'phone': '93804422'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}