Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:50 AM
Study NCT ID:
NCT07394595
Status:
COMPLETED
Last Update Posted:
2026-03-17
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upper Versus Lower Limb Cycling Exercise With Electrical Muscle Stimulation on Perceptual Responses, Energy Feelings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-15', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceptual Responses', 'timeFrame': 'at baseline and at 8 weeks', 'description': 'Assessed using the Rate of Perceived Exertion (RPE) scale.'}, {'measure': 'Self-Perceived Energy Feeling', 'timeFrame': 'at baseline and at 8 weeks', 'description': '(All participants will fill a short questionnaire (from 1 to 5 points) about their perception of energy before every training. Energy Feeling will be assessed (Evergy level, Fatigue Level, Feeling of Alertness, and Feeling of Focus for the task, valued from 1 = low energy to 5 = high energy).'}], 'secondaryOutcomes': [{'measure': 'Perception of Effort during Endurance Training', 'timeFrame': 'at baseline and at 8 weeks', 'description': '(Borg Scale (6-20) will be used to collect the perception of effort during endurance training (every 5 minutes) and 15-20 minutes after each session).'}, {'measure': 'Blood lactate concentration', 'timeFrame': 'at baseline and at 8 weeks', 'description': 'measured using capillary puncture during submaximal and maximal incremental exercise'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'In comparing the two types of cycling exercises, the perceptual responses, such as perceived exertion and fatigue, as well as subjective feelings of energy, are crucial metrics. Lower limb cycling is traditionally associated with higher levels of exertion due to the larger muscle groups involved. However, when EMS is applied, both upper and lower limb cycling might exhibit altered perceptions of effort and energy levels, with EMS potentially equalizing the exertional differences. This research is significant for designing exercise programs that optimize energy expenditure and enhance performance, particularly in rehabilitative settings or for individuals looking to diversify their physical training regimens.', 'detailedDescription': 'Perceptual responses, such as perceived exertion and enjoyment, play a critical role in exercise adherence and overall experience. By examining the differences in these responses between upper and lower limb cycling combined with EMS, we can identify which modality might be more favorable for maintaining motivation and engagement in young adults. This demographic is particularly crucial as they transition into lifelong fitness habits. Exploring how EMS impacts these perceptual responses can provide insights into optimizing exercise regimens for enhanced user experiences, potentially leading to better adherence and improved fitness outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-45 years\n* No history of cardiovascular or musculoskeletal disorders\n* Physically active individuals with a minimum of 150 minutes of moderate exercise per week\n\nExclusion Criteria:\n\n* Current use of medications affecting muscle function\n* Pregnant or lactating individuals\n* Involvement in other structured exercise programs'}, 'identificationModule': {'nctId': 'NCT07394595', 'briefTitle': 'Upper Versus Lower Limb Cycling Exercise With Electrical Muscle Stimulation on Perceptual Responses, Energy Feelings', 'organization': {'class': 'OTHER', 'fullName': 'MTI University'}, 'officialTitle': 'Upper Versus Lower Limb Cycling Exercise With Electrical Muscle Stimulation on Perceptual Responses, Energy Feelings in Young Adults', 'orgStudyIdInfo': {'id': 'IRB # 29/7/2024-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Upper Limb Cycling with EMS', 'description': 'Participants will perform cycling exercises using an arm ergometer combined with EMS applied to the upper limbs,Upper Limb Cycling with EMS: Participants will perform cycling exercises using an arm ergometer combined with EMS applied to the upper limbs. (Biceps, triceps, and deltoids) Jones et al., 2011', 'interventionNames': ['Other: Upper Limb Cycling with EMS']}, {'type': 'EXPERIMENTAL', 'label': 'Lower Limb Cycling with EMS', 'description': 'Participants will engage in traditional cycling exercises using a stationary bike with EMS applied to the lower limbs,Lower Limb Cycling with EMS: Participants will engage in traditional cycling exercises using a stationary bike with EMS applied to the lower limbs. (Quadriceps, hamstrings, and calf muscles) Bax et al., 2005', 'interventionNames': ['Other: Lower Limb Cycling with EMS']}, {'type': 'EXPERIMENTAL', 'label': 'EMS upper and lower', 'description': 'electrical stimulation upper and lower', 'interventionNames': ['Other: EMS upper and lower']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No exercises or intervention'}], 'interventions': [{'name': 'Upper Limb Cycling with EMS', 'type': 'OTHER', 'description': 'Upper Limb Cycling with EMS: Participants will perform cycling exercises using an arm ergometer combined with EMS applied to the upper limbs. (Biceps, triceps, and deltoids) Jones et al., 2011', 'armGroupLabels': ['Upper Limb Cycling with EMS']}, {'name': 'Lower Limb Cycling with EMS', 'type': 'OTHER', 'description': 'Lower Limb Cycling with EMS: Participants will engage in traditional cycling exercises using a stationary bike with EMS applied to the lower limbs. (Quadriceps, hamstrings, and calf muscles)', 'armGroupLabels': ['Lower Limb Cycling with EMS']}, {'name': 'EMS upper and lower', 'type': 'OTHER', 'description': 'EMS applied to the lower limbs. (Quadriceps, hamstrings, and calf muscles) and EMS applied to the upper limbs. (Biceps, triceps, and deltoids)', 'armGroupLabels': ['EMS upper and lower']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11311', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'faculty of physical therapy ,Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MTI University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant professor', 'investigatorFullName': 'Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d', 'investigatorAffiliation': 'MTI University'}}}}