Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:09 AM
Study NCT ID:
NCT07445568
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-Based Quadriceps Isometric Exercise for Knee Osteoarthritis Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002185', 'term': 'Cannabidiol'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants were blinded to topical treatment allocation through identical packaging and appearance of formulations. Investigators responsible for data collection were not involved in treatment assignment. Exercise allocation could not be blinded due to the nature of the intervention, and outcomes were self-reported.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Participants were randomized to a 4×2 factorial design. Four topical treatment conditions (placebo, cannabidiol, arnica, cannabidiol plus arnica) were combined with two exercise conditions (home-based quadriceps isometric exercise vs no exercise), resulting in eight parallel intervention groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in knee pain intensity measured by Visual Analog Scale (VAS)', 'timeFrame': 'Baseline to Day 28', 'description': 'Knee pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). The primary endpoint is the change from baseline to Day 28. Higher scores indicate greater pain.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in quadriceps isometric strength', 'timeFrame': 'Baseline to Day 28', 'description': 'Maximal voluntary isometric quadriceps strength will be measured using handheld dynamometry. The outcome will be expressed as peak force (kg or N). Change from baseline to Day 28 will be analyzed.'}, {'measure': 'Change from baseline in body composition', 'timeFrame': 'Baseline to Day 28', 'description': 'Lean mass and fat mass will be assessed using bioelectrical impedance analysis. Change from baseline to Day 28 will be evaluated.'}, {'measure': 'Exercise and topical treatment adherence', 'timeFrame': 'Throughout the 28-day intervention', 'description': 'Adherence will be calculated as the percentage of prescribed sessions/applications completed according to daily logs.'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline to Day 28', 'description': 'Frequency and type of adverse events related to topical formulations or exercise will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Isometric exercise', 'Home-based rehabilitation', 'Physical therapy', 'Non-pharmacological treatment', 'Pain management', 'Topical cannabidiol', 'Arnica montana'], 'conditions': ['Older Adults (60 - 85 Years Old)', 'OA Knee']}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis is a common cause of pain and reduced mobility in older adults. Many people have limited access to supervised rehabilitation programs, highlighting the need for simple and safe home-based treatment options.\n\nThis study evaluates whether a brief home-based quadriceps isometric exercise program can reduce knee pain in community-dwelling older adults. Participants perform short daily muscle contractions of the thigh muscles for 28 days. In addition, participants are assigned to receive one of four topical formulations (placebo, cannabidiol, arnica, or a combination of cannabidiol and arnica) to explore whether these products modify the exercise response.\n\nThe primary outcome is change in knee pain intensity measured using a visual analog scale. Secondary outcomes include adherence and safety. This pilot study aims to assess the feasibility, safety, and preliminary effectiveness of this low-cost and easily accessible strategy to inform future larger clinical trials.', 'detailedDescription': 'This study is a prospective randomized 4×2 factorial pilot trial conducted in community-dwelling older adults with symptomatic knee osteoarthritis. The purpose is to evaluate the feasibility, safety, and preliminary effectiveness of a brief home-based quadriceps isometric exercise program for short-term pain reduction, and to explore whether topical cannabidiol (CBD), arnica, or their combination modify the exercise response.\n\nParticipants are randomly assigned to one of four topical treatment groups (placebo, CBD, arnica, or CBD + arnica) and stratified to either an exercise or no-exercise condition, resulting in eight factorial subgroups. Randomization is computer-generated with allocation concealment using sequentially numbered opaque sealed envelopes.\n\nThe intervention period lasts 28 days. Participants allocated to the exercise condition perform daily quadriceps isometric contractions at home consisting of three sets of 10-second near-maximal voluntary contractions with rest intervals, requiring approximately 6 minutes per day. Topical formulations are applied twice daily to the affected knee. Adherence is monitored using daily logs.\n\nThe primary outcome is change in knee pain intensity measured using a Visual Analog Scale (VAS) at day 28. Secondary outcomes include feasibility indicators (adherence and retention), safety (adverse events), and exploratory changes in anthropometric and body composition measures.\n\nAnalyses are exploratory and include factorial ANCOVA adjusted for baseline values to estimate main effects of exercise and topical treatment, as well as interaction effects. Effect sizes are calculated to aid clinical interpretation.\n\nAs a pilot study, results are intended to inform the design and sample size estimation of future adequately powered randomized controlled trials evaluating low-cost, home-based rehabilitation strategies for older adults with knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 65 years or older\n\nClinical diagnosis of chronic knee osteoarthritis according to American College of Rheumatology criteria\n\nKnee pain for ≥3 months\n\nBaseline knee pain intensity ≥4 on a 10-cm Visual Analog Scale (VAS)\n\nAbility to walk independently with or without assistive devices\n\nAbility to understand study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Recent knee surgery or intra-articular injection within the last 3 months\n\nPlanned knee surgery during the study period\n\nSevere neurological or cardiovascular conditions limiting exercise participation\n\nSkin lesions or hypersensitivity to topical formulations\n\nCurrent use of topical analgesics on the target knee\n\nCognitive impairment preventing adherence to the protocol\n\nParticipation in another clinical trial within the last 30 days'}, 'identificationModule': {'nctId': 'NCT07445568', 'acronym': 'KOA-ISO01', 'briefTitle': 'Home-Based Quadriceps Isometric Exercise for Knee Osteoarthritis Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidad del Valle de México, Campus Cuernavaca'}, 'officialTitle': 'Home-based Quadriceps Isometric Exercise as a First-Line Rehabilitation Strategy for Knee Osteoarthritis Pain in Community-Dwelling Older Adults: A Randomized Factorial Pilot Trial', 'orgStudyIdInfo': {'id': 'UVM-KOAISO-01-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm Title Placebo Topical + Isometric Exercise', 'description': 'Participants received placebo topical gel twice daily plus daily home-based quadriceps isometric exercise for 28 days.', 'interventionNames': ['Drug: Placebo Topical Gel', 'Behavioral: Home-based Quadriceps Isometric Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo Topical Only', 'description': 'Participants received placebo topical gel twice daily without exercise.', 'interventionNames': ['Drug: Placebo Topical Gel']}, {'type': 'EXPERIMENTAL', 'label': 'CBD Topical + Isometric Exercise', 'description': 'Participants received cannabidiol topical formulation twice daily plus daily home-based quadriceps isometric exercise.', 'interventionNames': ['Drug: Cannabidiol (CBD) Topical Gel', 'Behavioral: Home-based Quadriceps Isometric Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'CBD Topical Only', 'description': 'Participants received cannabidiol topical formulation twice daily without exercise.', 'interventionNames': ['Drug: Cannabidiol (CBD) Topical Gel']}, {'type': 'EXPERIMENTAL', 'label': 'Arnica Topical + Isometric Exercise', 'description': 'Participants received Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise.', 'interventionNames': ['Drug: Arnica montana Topical Gel', 'Behavioral: Home-based Quadriceps Isometric Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Arnica Topical Only', 'description': 'Participants received Arnica montana topical formulation twice daily without exercise.', 'interventionNames': ['Drug: Arnica montana Topical Gel']}, {'type': 'EXPERIMENTAL', 'label': 'CBD + Arnica Topical + Exercise', 'description': 'Participants received combined cannabidiol and Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise.', 'interventionNames': ['Behavioral: Home-based Quadriceps Isometric Exercise', 'Drug: CBD + Arnica Topical Gel']}, {'type': 'EXPERIMENTAL', 'label': 'CBD + Arnica Topical Only', 'description': 'Participants received combined cannabidiol and Arnica montana topical formulation twice daily without exercise.', 'interventionNames': ['Drug: CBD + Arnica Topical Gel']}], 'interventions': [{'name': 'Placebo Topical Gel', 'type': 'DRUG', 'description': 'Placebo topical formulation without active pharmacological ingredients, applied twice daily to the affected knee for 28 days.', 'armGroupLabels': ['Arm Title Placebo Topical + Isometric Exercise', 'Placebo Topical Only']}, {'name': 'Cannabidiol (CBD) Topical Gel', 'type': 'DRUG', 'description': 'Topical cannabidiol formulation applied twice daily to the affected knee for 28 days.', 'armGroupLabels': ['CBD Topical + Isometric Exercise', 'CBD Topical Only']}, {'name': 'Arnica montana Topical Gel', 'type': 'DRUG', 'description': 'Topical Arnica montana formulation applied twice daily to the affected knee for 28 days.', 'armGroupLabels': ['Arnica Topical + Isometric Exercise', 'Arnica Topical Only']}, {'name': 'Home-based Quadriceps Isometric Exercise', 'type': 'BEHAVIORAL', 'description': 'Daily home-based quadriceps isometric exercise protocol consisting of three sets of 10-second near-maximal voluntary contractions with rest intervals, performed for 28 days.', 'armGroupLabels': ['Arm Title Placebo Topical + Isometric Exercise', 'Arnica Topical + Isometric Exercise', 'CBD + Arnica Topical + Exercise', 'CBD Topical + Isometric Exercise']}, {'name': 'CBD + Arnica Topical Gel', 'type': 'DRUG', 'description': 'combined cannabidiol and arnica formulation applied twice daily', 'armGroupLabels': ['CBD + Arnica Topical + Exercise', 'CBD + Arnica Topical Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62790', 'city': 'Xochitepec', 'state': 'Morelos', 'country': 'Mexico', 'facility': 'Hospital Regional de Alta Especialidad "Centenario de la Revolución Mexicana" - ISSSTE, Servicio de Alimentación y Nutrición Clínica', 'geoPoint': {'lat': 18.7808, 'lon': -99.23049}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to institutional privacy policies and protection of patient confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad del Valle de México, Campus Cuernavaca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}