Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:34 PM
Study NCT ID:
NCT07440433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-Based Physiotherapy in Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention rate', 'timeFrame': '6 months', 'description': 'Percentage of participants completing the 6-month intervention and final assessments.'}, {'measure': 'Adherence to prescribed exercise sessions', 'timeFrame': '6 months', 'description': 'Percentage of planned home-based exercise sessions completed over 6 months.'}, {'measure': 'Equipment installation and usability', 'timeFrame': '6 months', 'description': 'Percentage of participants with successful delivery, installation, and safe use of the home-based exercise equipment.'}, {'measure': 'Safety of the intervention', 'timeFrame': '6 months', 'description': 'Number and type of adverse events and serious adverse events related to the programme.'}], 'secondaryOutcomes': [{'measure': '6-minute walk test', 'timeFrame': 'Baseline and 6 months', 'description': 'Distance walked during the 6-minute walk test (meters).'}, {'measure': 'Peak oxygen uptake (VO₂peak)', 'timeFrame': 'Baseline and 6 months', 'description': 'Peak oxygen uptake measured during cardiopulmonary exercise testing (CPET), expressed in mL/kg/min.'}, {'measure': '5 Times Sit-to-Stand Test (5xSST)', 'timeFrame': 'Baseline and 6 months', 'description': 'Time to complete five sit-to-stand repetitions (seconds).'}, {'measure': 'Handgrip strength', 'timeFrame': 'Baseline and 6 months', 'description': 'Maximal grip strength measured with a dynamometer (kilograms).'}, {'measure': 'Health-related quality of life (EORTC QLQ-C30 global health status score)', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Quality of life assessed using the EORTC QLQ-C30 questionnaire. Scores range from 0 to 100. Higher scores on the global health status scale indicate better quality of life.'}, {'measure': 'Participant satisfaction score', 'timeFrame': '3 months and 6 months', 'description': 'Participant satisfaction assessed using a study-specific questionnaire (score range 0-10, higher scores indicate greater satisfaction).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rehabilitation Exercise', 'Oncologic Diseases']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to assess the feasibility, acceptability, and safety of a supervised home-based physiotherapy programme for adult oncology patients. The programme combines aerobic cycling exercise, resistance training, and mental preparation strategies, delivered at home with regular professional supervision.\n\nThe main questions this study aims to answer are:\n\nIs a 6-month supervised home-based physiotherapy programme feasible in terms of recruitment, adherence, and retention?\n\nIs the programme safe for oncology patients undergoing or having recently completed cancer treatment?\n\nIs the programme acceptable and satisfactory from the patient's perspective?\n\nHow do physical function and health-related quality of life change over the course of the programme?\n\nThis is a single-arm feasibility study with no comparison group.\n\nParticipants will:\n\nReceive a stationary exercise bike delivered and installed at their home\n\nFollow a 6-month individualized physiotherapy programme including:\n\nThree weekly sessions combining moderate-intensity cycling and resistance exercises\n\nWear a connected activity watch during exercise sessions to monitor heart rate and exercise duration\n\nReceive weekly supervision from oncology-trained physiotherapists through alternating in-person hospital visits and structured phone calls\n\nComplete physical function assessments and questionnaires on quality of life, fatigue, and programme satisfaction at baseline, mid-program, and study completion\n\nThe results of this study will inform the design of a future larger controlled trial and contribute to the development of accessible home-based rehabilitation programmes for oncology patients.", 'detailedDescription': "This study is a prospective, single-centre, single-arm feasibility clinical trial conducted at the Geneva University Hospitals (HUG). It evaluates the implementation of a long-duration supervised home-based physiotherapy programme for adult oncology patients.\n\nA total of 21 participants will be enrolled in three sequential cohorts of approximately seven participants each. Each participant will follow a single 6-month intervention period; cohorts are implemented sequentially for logistical and organisational reasons but follow identical study procedures.\n\nThe intervention consists of a 6-month home-based physiotherapy programme combining aerobic cycling exercise, resistance training, and mental preparation strategies. At study initiation, a stationary exercise bike is delivered and installed in the participant's home. An individualized exercise prescription is developed by oncology-trained physiotherapists based on baseline functional assessments and clinical status.\n\nParticipants are asked to complete three supervised exercise sessions per week. Each session includes approximately 20 minutes of moderate-intensity aerobic cycling followed by 20 minutes of resistance training. Exercise intensity is prescribed and monitored using perceived exertion and heart rate criteria consistent with current oncology exercise guidelines. A connected activity watch is provided to each participant and worn only during exercise sessions to record heart rate and exercise duration.\n\nSupervision is ensured through weekly contact with oncology physiotherapists, alternating between in-person hospital visits and structured telephone calls. In-person visits include functional reassessments, programme adjustments, symptom review, safety monitoring, and mental preparation sessions. Mental preparation integrates motivational interviewing techniques, goal setting, routine development, and basic mindfulness and imagery strategies aimed at supporting adherence and self-management.\n\nThe primary focus of the study is feasibility, assessed through recruitment capability, adherence to prescribed exercise sessions, participant retention over the 6-month period, and successful delivery and use of the home-based equipment. Safety is assessed through systematic monitoring and reporting of adverse events related to the intervention.\n\nSecondary outcomes include changes in physical function and patient-reported outcomes. Functional performance is assessed using standardized physical tests at baseline and at the end of the intervention. Patient-reported outcomes, including health-related quality of life, fatigue, and programme acceptability, are collected at baseline, mid-program (3 months), and study completion (6 months).\n\nAll analyses are descriptive and aim to provide feasibility indicators and operational insights to inform the design of a future controlled trial and potential integration of supervised home-based physiotherapy into routine oncology care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of solid cancer, undergoing or recently completed treatment.\n* Overall survival greater than 12 months, as judged by the treating oncologist\n* Clinically stable and deemed fit for moderate exercise by the treating oncologist\n* Able to use an exercise bike\n* Home environment suitable for delivery and installation of the exercise bike\n* Able to understand the study language and follow study instructions\n* Able to give a written informed consent\n\nExclusion Criteria:\n\n* Medical contraindication to moderate exercise (e.g. uncontrolled cardiac or pulmonary disease, recent myocardial infarction, severe anemia or acute infection, unstable bone metastases or high fracture risk)\n* Cognitive impairment preventing active participation\n* Physical inability to perform the prescribed exercise programme, including cycling and resistance exercises.\n* Participation in another intensive rehabilitation program\n* Any other condition that, in the opinion of the treating oncologist or investigator, makes participation unsafe or not feasible\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT07440433', 'briefTitle': 'Home-Based Physiotherapy in Oncology', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Home-Based Physiotherapy for Oncology Patients: Feasibility and Acceptability of a Supervised Exercise Programme', 'orgStudyIdInfo': {'id': 'PRADA-HUG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Home-based supervised physiotherapy programme', 'description': 'Participants enrolled in this single-arm study receive a 6-month supervised home-based physiotherapy programme combining aerobic cycling, resistance training, and mental preparation, delivered and monitored by oncology-trained physiotherapists.', 'interventionNames': ['Behavioral: Home-based cycling + resistance training with physiotherapist supervision']}], 'interventions': [{'name': 'Home-based cycling + resistance training with physiotherapist supervision', 'type': 'BEHAVIORAL', 'description': "Participants complete a 6-month supervised home-based physiotherapy programme. The intervention includes three weekly exercise sessions consisting of approximately 20 minutes of moderate-intensity aerobic cycling followed by 20 minutes of resistance training. Exercise intensity is prescribed and monitored using perceived exertion and heart rate.\n\nA stationary exercise bike is delivered and installed at the participant's home. Participants receive weekly supervision by oncology-trained physiotherapists through alternating in-person hospital visits and structured telephone calls. Mental preparation strategies, including motivational support and goal setting, are integrated during in-person visits to support adherence and self-management.", 'armGroupLabels': ['Home-based supervised physiotherapy programme']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'HUG', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Floryane Dr Kim', 'role': 'CONTACT', 'email': 'floryane.kim@hug.ch', 'phone': '+41 22 372 98 62'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Floryane Kim', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}