Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:02 AM
Study NCT ID:
NCT07468968
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-18
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Balance and Inspiratory Muscle Training in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a 3-arm, parallel-group randomized controlled trial. Participants will be allocated to one of the three intervention arms (Inspiratory Muscle Training group, Balance Training group, or Combined Training group) in a 1:1:1 ratio. A block randomization method will be employed to ensure an equal distribution of gender across all groups. The study follows a pre-test and post-test design, where all outcome measures are assessed at baseline and immediately following the 8-week intervention period.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Inspiratory Pressure (MIP)', 'timeFrame': 'Baseline and 8 weeks.', 'description': 'MIP will be measured using a digital pressure gauge to evaluate the strength of the inspiratory muscles. The best of three maneuvers will be recorded in cmH2O. Higher values indicate better respiratory muscle strength.'}, {'measure': 'Maximal Expiratory Pressure (MEP)', 'timeFrame': 'Baseline and 8 weeks.', 'description': 'MEP will be measured using a digital pressure gauge to evaluate the strength of the expiratory muscles. The best of three maneuvers will be recorded in cmH2O. Higher values indicate better expiratory muscle strength.'}, {'measure': 'Timed Up and Go (TUG) Test', 'timeFrame': 'Baseline and 8 weeks.', 'description': 'The TUG test measures the time (in seconds) it takes for a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Lower scores (less time) indicate better functional mobility and balance.'}, {'measure': 'Respiratory Muscle Endurance (Incremental Threshold Loading Test)', 'timeFrame': 'Baseline and 8 weeks.', 'description': "Respiratory muscle endurance will be assessed using an incremental threshold loading test (ITLT). The test starts with an initial load based on the participant's Maximal Inspiratory Pressure (MIP). The resistance is increased by 20% of the initial MIP value every 2 minutes. Participants are instructed to maintain their breathing pattern against the increasing load until exhaustion or until they can no longer overcome the threshold. The total duration (in seconds) sustained during the test is recorded. Higher values indicate better respiratory muscle endurance."}, {'measure': 'Single Leg Stance Test (SLST)', 'timeFrame': 'Baseline and 8 weeks.', 'description': 'The participant stands on one leg for as long as possible without support. The time (in seconds) until balance is lost is recorded (up to a maximum of 30 or 60 seconds). Higher values indicate better static balance.'}, {'measure': '6-Minute Walk Test (6MWT)', 'timeFrame': 'Baseline and 8 weeks.', 'description': 'The 6MWT measures the total distance (in meters) a participant can walk on a flat, hard surface in a period of 6 minutes. It is used to assess submaximal functional exercise capacity.'}, {'measure': 'Core Muscle Endurance Test', 'timeFrame': 'Baseline and 8 weeks.', 'description': "Core endurance will be assessed using static holding test (McGill's torso endurance test). The duration (in seconds) the participant can maintain the position is recorded. Higher duration indicates better core stability."}], 'secondaryOutcomes': [{'measure': 'Short Physical Performance Battery (SPPB)', 'timeFrame': 'Baseline and 8 weeks.', 'description': 'SPPB consists of three components: standing balance, gait speed, and chair stand tests. Each component is scored from 0 to 4, with a total score ranging from 0 to 12. Higher scores indicate better physical performance.'}, {'measure': 'Charlson Comorbidity Index (CCI)', 'timeFrame': 'Baseline.', 'description': 'This index categorizes or weights comorbid conditions to predict the 10-year survival for patients. The scores are summed to provide a total score (0 to 37). Higher scores indicate a higher burden of comorbidity and a lower 10-year survival probability.'}, {'measure': 'Mini-Mental State Examination (MMSE)', 'timeFrame': 'Baseline.', 'description': 'A 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. Scores range from 0 to 30. Higher scores indicate better cognitive function.'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Baseline.', 'description': 'A rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Total score is 30. Higher scores indicate better cognitive performance.'}, {'measure': 'Tinetti Performance-Oriented Mobility Assessment (POMA)', 'timeFrame': 'Baseline and 8 weeks.', 'description': "A task-oriented test that measures an older adult's gait and balance abilities. The maximum score is 28, with 16 points for balance and 12 for gait. Higher scores indicate better mobility and lower fall risk."}, {'measure': 'Handgrip Strength', 'timeFrame': 'Baseline and 8 weeks.', 'description': 'Handgrip strength will be measured in kilograms (kg) using a calibrated handheld dynamometer. Participants will perform three trials with their dominant hand, and the maximum value will be recorded. Higher values indicate better upper extremity muscle strength.'}, {'measure': 'Physical Activity Scale for the Elderly (PASE)', 'timeFrame': 'Baseline.', 'description': 'A brief instrument to assess physical activity in older adults. It scores occupational, household, and leisure activities over a one-week period. Higher scores indicate a higher level of physical activity.'}, {'measure': 'Fatigue Impact Scale (FIS)', 'timeFrame': 'Baseline.', 'description': "A self-reported questionnaire that measures the impact of fatigue on daily functioning and quality of life. Higher scores indicate a greater impact of fatigue on the individual's life."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['geriatrics', 'balance', 'respiratory muscle strength', 'functional capacity', 'fall risk'], 'conditions': ['Geriatric', 'Geriatrics Rehabilitation', 'Geriatric Fall', 'Geriatric Health']}, 'referencesModule': {'references': [{'pmid': '31978126', 'type': 'BACKGROUND', 'citation': 'Ferraro FV, Gavin JP, Wainwright TW, McConnell AK. Comparison of balance changes after inspiratory muscle or Otago exercise training. PLoS One. 2020 Jan 24;15(1):e0227379. doi: 10.1371/journal.pone.0227379. eCollection 2020.'}, {'pmid': '34530401', 'type': 'BACKGROUND', 'citation': 'Ferraro FV, Gavin JP, Wainwright TW, McConnell AK. Association Between Inspiratory Muscle Function and Balance Ability in Older People: A Pooled Data Analysis Before and After Inspiratory Muscle Training. J Aging Phys Act. 2022 Jun 1;30(3):421-433. doi: 10.1123/japa.2020-0507. Epub 2021 Sep 16.'}, {'pmid': '29549494', 'type': 'BACKGROUND', 'citation': 'Rodrigues GD, Gurgel JL, Goncalves TR, da Silva Soares PP. Inspiratory muscle training improves physical performance and cardiac autonomic modulation in older women. Eur J Appl Physiol. 2018 Jun;118(6):1143-1152. doi: 10.1007/s00421-018-3844-9. Epub 2018 Mar 16.'}, {'pmid': '23835773', 'type': 'BACKGROUND', 'citation': 'Cebria i Iranzo Md, Arnall DA, Igual Camacho C, Tomas JM. Effects of inspiratory muscle training and yoga breathing exercises on respiratory muscle function in institutionalized frail older adults: a randomized controlled trial. J Geriatr Phys Ther. 2014 Apr-Jun;37(2):65-75. doi: 10.1519/JPT.0b013e31829938bb.'}, {'pmid': '27384328', 'type': 'BACKGROUND', 'citation': 'Pessoa MF, Brandao DC, Sa RB, Barcelar JM, Rocha TDS, Souza HCM, Dornelas de Andrade A. Vibrating Platform Training Improves Respiratory Muscle Strength, Quality of Life, and Inspiratory Capacity in the Elderly Adults: A Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2017 May 1;72(5):683-688. doi: 10.1093/gerona/glw123.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate and compare the effects of Inspiratory Muscle Training (IMT), balance training, and a combination of both on respiratory muscle strength and balance in older adults. Aging is often associated with a decline in skeletal and respiratory muscle strength, which can increase the risk of falls and impact overall functionality.\n\nParticipants aged 60 and over will be randomly assigned to one of three groups:\n\nRespiratory Muscle Training group (30 breaths, twice daily),\n\nBalance Training group (45-50 minute sessions, 3 days a week),\n\nCombined Training group (both IMT and balance exercises).\n\nThe intervention will last for 8-weeks. Researchers will evaluate respiratory muscle strength, balance, core endurance, and functional capacity before and after the 8-week program to determine which approach is most effective in improving these parameters in the geriatric population.', 'detailedDescription': 'This is a 3-arm randomized comparative trial designed to evaluate the synergistic effects of respiratory and physical interventions in the geriatric population. Physiological changes due to aging, such as reduced inspiratory muscle pressure (MIP) and impaired postural control, are closely linked to increased mortality and fall risk. This study tests the hypothesis that combining IMT with balance training will yield superior outcomes compared to single-mode interventions.\n\nMethodology and Interventions:\n\nParticipants will be allocated into three groups using block randomization to ensure gender balance (n=12 per group, total target n=36, accounting for a 20% potential attrition rate):\n\nGroup 1 (IMT): Participants will perform 30 breaths twice daily using an IMT device for 8 weeks.\n\nGroup 2 (Balance): Participants will attend 45-50 minute supervised balance training sessions, 3 days per week for 8 weeks.\n\nGroup 3 (Combined): Participants will perform both the daily IMT protocol and the thrice-weekly balance sessions.\n\nEvaluation Criteria:\n\nOutcomes will be measured at baseline and after the 8-week intervention. Primary outcomes include Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP), Timed Up and Go (TUG) test, Short Physical Performance Battery (SPPB), 6-Minute Walk Test (6MWT), core endurance tests, and single-leg stance balance.\n\nData from participants who complete at least 70% of the training sessions will be included in the final analysis. The study aims to provide evidence-based recommendations for enhancing functional independence and reducing fall risk in older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 60 years or older.\n* Mini-Mental State Examination (MMSE) score of 22 or higher.\n* Ability to walk 10 meters independently without human assistance.\n* Ability to read and write.\n* Volunteering to participate and providing written informed consent.\n\nExclusion Criteria:\n\n* Current use of sedative or hypnotic medications.\n* Presence of a diagnosed neurological disorder (e.g., history of stroke, Parkinson's disease, Multiple Sclerosis, dementia, or clinical vertigo) that is currently under treatment.\n* Presence of clinically significant cardiovascular or pulmonary complications (e.g., COPD, active lung disease, or uncontrolled hypertension).\n* Severe postural abnormalities that may interfere with the study (e.g., advanced scoliosis or kyphosis).\n* Acute or chronic orthopedic conditions preventing participation in a balance exercise program (e.g., lower extremity fractures or severe joint instability).\n* High risk of sarcopenia, defined as a SARC-F score of 4 or higher.\n* Significant communication or cognitive barriers that prevent following the exercise instructions."}, 'identificationModule': {'nctId': 'NCT07468968', 'briefTitle': 'Comparative Effects of Balance and Inspiratory Muscle Training in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Comparative Effects of Balance and Inspiratory Muscle Training on Balance, Respiratory Muscle Strength, and Physical Performance in Older Adults: A Randomized Comparative Trial', 'orgStudyIdInfo': {'id': '2025-03-17.12.2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inspiratory Muscle Training', 'description': 'Participants will perform inspiratory muscle training using a threshold device. The protocol consists of 30 breaths, twice daily (60 breaths total per day), for 7 days a week over a period of 8 weeks.', 'interventionNames': ['Device: Inspiratory Muscle Training']}, {'type': 'EXPERIMENTAL', 'label': 'Balance Training', 'description': 'Participants will receive a supervised balance training program. The sessions will be held 3 days per week, each lasting 45-50 minutes, for a total duration of 8 weeks.', 'interventionNames': ['Behavioral: Balance Training']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Training Group (IMT + Balance)', 'description': 'Participants will receive both interventions concurrently. This includes the daily IMT protocol (30 breaths, twice daily) and the supervised balance training sessions (45-50 minutes, 3 days per week) for 8 weeks.', 'interventionNames': ['Device: Inspiratory Muscle Training', 'Behavioral: Balance Training']}], 'interventions': [{'name': 'Inspiratory Muscle Training', 'type': 'DEVICE', 'otherNames': ['Threshold IMT', 'Respiratory Muscle Training.'], 'description': "Participants will use a threshold inspiratory muscle trainer device. The training involves performing 30 breaths twice a day (morning and evening), 7 days a week for 8 consecutive weeks. The resistance (intensity) will be adjusted based on the participant's maximal inspiratory pressure (MIP) to ensure progressive training.", 'armGroupLabels': ['Combined Training Group (IMT + Balance)', 'Inspiratory Muscle Training']}, {'name': 'Balance Training', 'type': 'BEHAVIORAL', 'description': 'A structured balance training program conducted under the supervision of a therapist. Sessions last 45-50 minutes, held 3 days per week for 8 weeks. The program includes static and dynamic balance exercises, weight-shifting tasks, and functional movement patterns designed to reduce fall risk.', 'armGroupLabels': ['Balance Training', 'Combined Training Group (IMT + Balance)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Darülaceze Müdürlüğü', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biruni University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}