Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT07302204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Aerobic Exercise Versus Therapeutic Exercises on Exercise-induced Hypoalgesia in Knee Osteoarthritis. Randomized Clinical Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise-induced hypoalgesia (EIH)', 'timeFrame': 'At weeks 1, 4, 7, and 10 of the 10 week intervention (within session, pre and immediately post exercise).', 'description': 'exercise induced hypoalgesia (EIH) of the medial compartment of the knees, measured by the change in pressure pain threshold (Δ PPT)'}], 'secondaryOutcomes': [{'measure': 'Exercise induced hypoalgesia of the quadriceps', 'timeFrame': 'Within session, immediately before and immediately after the exercise session at weeks 1, 4, 7, and 10 of the 10 week intervention.', 'description': 'Within session change in pressure pain threshold at the rectus femoris muscle, calculated as post exercise minus pre exercise values and averaged bilaterally, measured with a digital algometer and expressed in kilograms force per square centimeter.'}, {'measure': 'Exercise induced hypoalgesia of the upper trapezius', 'timeFrame': 'Within session, immediately before and immediately after the exercise session at weeks 1, 4, 7, and 10 of the 10 week intervention.', 'description': 'Within session change in pressure pain threshold at the upper trapezius muscle descending portion, calculated as post exercise minus pre exercise values and averaged bilaterally, measured with a digital algometer and expressed in kilograms force per square centimeter.'}, {'measure': 'Chronic adaptation of pressure pain threshold', 'timeFrame': 'Baseline and after 10 weeks of intervention.', 'description': 'Change in pressure pain threshold at the medial compartment of the knee, rectus femoris and upper trapezius between baseline and post intervention, averaged bilaterally and expressed in kilograms force per square centimeter.'}, {'measure': 'Conditioned pain modulation', 'timeFrame': 'Baseline and after 10 weeks of intervention.', 'description': 'Change in the conditioned pain modulation effect assessed by a standardized conditioned pain modulation test, defined as the change in pressure pain threshold at the volar forearm during and after an ischemic conditioning stimulus on the contralateral arm, with pain intensity standardized around four out of ten on a numeric rating scale.'}, {'measure': 'Pain intensity', 'timeFrame': 'Baseline and after 10 weeks of intervention.', 'description': 'Average knee pain intensity over the last seven days at rest and after movement, measured by an eleven point numeric rating scale from zero no pain to ten worst imaginable pain.'}, {'measure': 'Pain self efficacy', 'timeFrame': 'Baseline and after 10 weeks of intervention.', 'description': 'Total score on the Pain Self Efficacy Questionnaire, ten items scored from zero not at all confident to six completely confident, summed to a total from zero to sixty, with higher scores indicating greater self efficacy to perform activities despite pain.'}, {'measure': 'Knee related health status', 'timeFrame': 'Baseline and after 10 weeks of intervention.', 'description': 'Subscale scores of the Knee injury and Osteoarthritis Outcome Score questionnaire Pain, Symptoms, Activities of Daily Living, Sport and Recreation, and Knee related Quality of Life, each transformed to a zero to one hundred score, in which higher scores indicate better knee related health status.'}, {'measure': 'Patient specific functional status', 'timeFrame': 'Baseline and after 10 weeks of intervention.', 'description': 'Average score of three patient selected daily activities rated with the Patient Specific Functional Scale Brazilian version, each activity scored from zero unable to perform to ten able as before the problem, higher scores indicating better functional status.'}, {'measure': 'Functional performance, thirty second sit to stand test', 'timeFrame': 'Baseline and after 10 weeks of intervention.', 'description': 'Number of full sit to stand repetitions completed from a standard height chair in thirty seconds, higher counts reflecting better lower limb strength, dynamic balance and functional performance.'}, {'measure': 'Quadriceps muscle strength', 'timeFrame': 'Baseline and after 10 weeks of intervention.', 'description': 'Maximal voluntary isometric contraction of the quadriceps measured with a handheld dynamometer in a standardized seated position, normalized to body mass and expressed as a percentage, with higher values indicating greater strength.'}, {'measure': 'Global perceived effect', 'timeFrame': 'After 10 weeks of intervention.', 'description': 'Score on the Global Perceived Effect scale, an eleven point scale from minus five very much worse through zero no change to plus five completely recovered, higher scores indicating greater perceived improvement in knee osteoarthritis related condition.'}, {'measure': 'Adherence to the intervention', 'timeFrame': 'Throughout the 10 week intervention period.', 'description': 'Proportion of attended exercise sessions relative to the thirty planned sessions, calculated as attendance percentage sessions attended divided by sessions planned multiplied by one hundred.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'The study compares two exercise strategies in people with knee osteoarthritis. The first is aerobic exercise on a recumbent cycle ergometer, with effort controlled by the Borg scale. The second is a therapeutic exercise program with resistance, neuromuscular, mobility, and balance components. The primary objective is to determine which approach produces greater exercise induced hypoalgesia, measured by the increase in pressure pain threshold at the knee within the session across four anchor sessions during a ten week program. This is a randomized clinical trial with two parallel arms. Ninety participants, between forty five and seventy five years of age, will be allocated to one of the two groups. Allocation sequence concealment will be ensured using opaque envelopes. The outcome assessor will remain blinded to group allocation. The interventions will take place three times per week for ten weeks. Assessments will be performed at baseline and after ten weeks. Within session measurements will also be taken in weeks one, four, seven, and ten. The primary outcome is the intra session change in pressure pain threshold at the medial compartment of the knee. Secondary outcomes include exercise induced hypoalgesia in the quadriceps and trapezius, chronic adaptation of pressure pain threshold, conditioned pain modulation, pain intensity, pain self efficacy, knee related health status, functional performance, quadriceps strength, global perceived effect, and adherence. The planned sample size is forty five participants per group. The analysis will follow the intention to treat principle. The primary outcome will be compared using linear mixed models with group and time effects. Clinical outcomes at T1 will be adjusted for baseline values. Estimates, confidence intervals, and interpretation in light of minimally important differences will be reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of symptomatic knee osteoarthritis for at least 3 months.\n* Report of knee pain for more than 3 months and average knee pain intensity ≥ 3 on the 0 to 10 Numeric Rating Scale.\n* Morning stiffness lasting less than 30 minutes.\n* Clinical signs compatible with knee osteoarthritis. crepitus, bony tenderness and absence of palpable warmth at the knee.\n\nExclusion Criteria:\n\n* Signs and symptoms indicating the hip as the main source of pain.\n* Osteoporosis\n* Fibromyalgia\n* History of tumors or cancer\n* Active inflammatory joint diseases, such as rheumatoid arthritis or gout.\n* Previous arthroplasty of any lower limb joint.\n* Neurological diseases, including Parkinson's disease, stroke, multiple sclerosis, muscular dystrophy, motor neuron disease or Alzheimer's disease.\n* Cardiovascular diseases for which exercise is formally contraindicated.\n* Infected wounds or osteomyelitis in the knee region.\n* Deep vein thrombosis or thrombophlebitis.\n* Sensory alterations in the lower limbs.\n* Cognitive or cardiopulmonary impairments that limit safe participation in the exercise program.\n* Use of walking aids.\n* Recent knee trauma."}, 'identificationModule': {'nctId': 'NCT07302204', 'briefTitle': 'Efficacy of Aerobic Exercise Versus Therapeutic Exercises on Exercise-induced Hypoalgesia in Knee Osteoarthritis. Randomized Clinical Trial.', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Efficacy of Aerobic Exercise Versus Therapeutic Exercises on Exercise-induced Hypoalgesia in Knee Osteoarthritis. Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '93560425.7.0000.5511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercise Group (AEG)', 'description': 'Participants allocated to the Aerobic Exercise Group (AEG) will perform supervised cycling on an electromagnetic recumbent stationary bicycle three times per week for ten weeks, with at least 24 hours between sessions. Each session will be structured as five minutes of warm up, a progressively longer work phase, and five minutes of cool down. Exercise intensity will be prescribed and monitored using the 6 to 20 Borg Rating of Perceived Exertion scale, targeting light to moderate exertion during warm up and cool down and moderate to somewhat hard exertion during the work phase. Cadence will be maintained around 60 to 80 revolutions per minute and the resistance level will be adjusted to keep participants within the target exertion zone.', 'interventionNames': ['Other: Aerobic Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Therapeutic Exercise Group (TEG)', 'description': 'Participants allocated to the Therapeutic Exercise Group will receive an individually supervised, land based therapeutic exercise program focusing on warm up, resisted strengthening, neuromuscular training, mobility and balance. Sessions will be performed three times per week for ten weeks, with at least 24 hours between sessions, and will last approximately 60 minutes. Therapeutic exercises will be completed in up to three sets of 8 to 12 repetitions in weeks 1 to 5 and 8 to 15 repetitions in weeks 6 to 10, each set lasting 30 to 60 seconds, with 90 second rest intervals between sets. Load for machine or free weight exercises will be prescribed at about 40 to 60 percent of the pain limited one repetition maximum, elastic band resistance will be set to allow 12 repetitions with pain ≤ 5 out of 10, and body weight exercises will be held for 30 to 60 seconds. Vital signs and knee pain intensity will be assessed before, during and after each session to guide safety and progression.', 'interventionNames': ['Other: Therapeutic Exercise']}], 'interventions': [{'name': 'Aerobic Exercise', 'type': 'OTHER', 'description': 'Supervised cycling on an electromagnetic recumbent stationary bicycle three times per week for ten weeks, with at least 24 hours between sessions.', 'armGroupLabels': ['Aerobic Exercise Group (AEG)']}, {'name': 'Therapeutic Exercise', 'type': 'OTHER', 'description': 'Individually supervised, land based therapeutic exercise program focusing on warm up, resisted strengthening, neuromuscular training, mobility and balance.', 'armGroupLabels': ['Therapeutic Exercise Group (TEG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01415000', 'city': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Cid Andre F Gomes, Phd', 'role': 'CONTACT', 'email': 'cid.andre@gmail.com'}], 'facility': 'Cid André Fidelis de Paula Gomes', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Cid Gomes, Phd', 'role': 'CONTACT', 'email': 'cid.andre@gmail.com', 'phone': '+5511970941936'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Phd', 'investigatorFullName': 'Cid André Fidelis de Paula Gomes', 'investigatorAffiliation': 'University of Nove de Julho'}}}}