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IRCT20260526069540N1 IRCT 2026-07-20 Allameh Tabataba'i University Investigation of the Effect of Respiratory Fatigue on Gait Pattern Comparing the effect of respiratory muscle fatigue on the gait pattern of active and inactive older adults 2026-07-23 anticipated 30 Recruiting https://irct.ir/trial/90466 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Aging. Intervention 1: Intervention Group 1 (Active Older Adults):The intervention in this study consists of the acute induction of respiratory muscle fatigue through inspiratory muscle resistance training using the PowerBreathe inspiratory muscle trainer. This device is an adjustable mechanical instrument that provides resistance during inspiration, allowing the training intensity to be individualized based on each participant's maximal inspiratory pressure (PImax).Prior to the intervention, each participant's maximal inspiratory pressure (PImax) is measured using a handheld mouth pressure manometer. Participants perform three maximal inspiratory efforts with one-minute rest intervals between attempts, and the highest recorded value is considered the baseline PImax.Following the determination of PImax, the resistance of the inspiratory muscle trainer is set at 60% of the participant's baseline PImax. Participants perform repeated forceful inspiratory breaths through the device while seated in a standardized upright position. The intervention is conducted as a single acute laboratory session and consists of one bout of inspiratory muscle resistance exercise performed until the criterion for respiratory muscle fatigue is reached.The protocol continues until the participant is unable to generate at least 90% of the baseline PImax in three consecutive maximal inspiratory efforts. This criterion is considered indicative of functional respiratory muscle fatigue. Once fatigue is confirmed, the participant immediately proceeds to the post-intervention walking assessment, during which spatiotemporal gait parameters are reassessed.The intervention is performed only once and is designed solely to induce acute, transient respiratory muscle fatigue. Therefore, it does not involve a multi-session training program or any form of long-term respiratory muscle training. Intervention 2: Intervention Group 2 (Inactive Older Adults):The intervention in this study consists of the acute induction of respiratory muscle fatigue through inspiratory muscle resistance training using the PowerBreathe inspiratory muscle trainer. This device is an adjustable mechanical instrument that provides resistance during inspiration, allowing the training intensity to be individualized based on each participant's maximal inspiratory pressure (PImax).Prior to the intervention, each participant's maximal inspiratory pressure (PImax) is measured using a handheld mouth pressure manometer. Participants perform three maximal inspiratory efforts with one-minute rest intervals between attempts, and the highest recorded value is considered the baseline PImax.Following the determination of PImax, the resistance of the inspiratory muscle trainer is set at 60% of the participant's baseline PImax. Participants perform repeated forceful inspiratory breaths through the device while seated in a standardized upright position. The intervention is conducted as a single acute laboratory session and consists of one bout of inspiratory muscle resistance exercise performed until the criterion for respiratory muscle fatigue is reached.The protocol continues until the participant is unable to generate at least 90% of the baseline PImax in three consecutive maximal inspiratory efforts. This criterion is considered indicative of functional respiratory muscle fatigue. Once fatigue is confirmed, the participant immediately proceeds to the post-intervention walking assessment, during which spatiotemporal gait parameters are reassessed.The intervention is performed only once and is designed solely to induce acute, transient respiratory muscle fatigue. Therefore, it does not involve a multi-session training program or any form of long-term respiratory muscle training. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the lack of plans for sharing individual participant data, no additional information is available.
public Reza Norouzi
No. 14, Ahmad Abbasi Alley, Moftazi Street, Navab Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1331684969 +98 916 927 3651 reznrz148@gmail.com Allameh Tabataba'i University scientific Reza Norouzi
No 81، Acadia Medical Equipment Passage Navab Highway، Tehran، Iran
Tehran Iran (Islamic Republic of) 1331684969 +98 916 927 3651 reznrz148@gmail.com Allameh Tabataba'i University Iran (Islamic Republic of) Being in the 65–70 age range Living in the city of Tehran Having the ability to carry out daily activities and participate in assessments Completing the Physical activity questionnaire to determine the individual's level of physical activity Having a body mass index (BMI) within the normal range 65 years 70 years Male Rehabilitation Rehabilitation Intervention Group 1 (Active Older Adults):The intervention in this study consists of the acute induction of respiratory muscle fatigue through inspiratory muscle resistance training using the PowerBreathe inspiratory muscle trainer. This device is an adjustable mechanical instrument that provides resistance during inspiration, allowing the training intensity to be individualized based on each participant's maximal inspiratory pressure (PImax).Prior to the intervention, each participant's maximal inspiratory pressure (PImax) is measured using a handheld mouth pressure manometer. Participants perform three maximal inspiratory efforts with one-minute rest intervals between attempts, and the highest recorded value is considered the baseline PImax.Following the determination of PImax, the resistance of the inspiratory muscle trainer is set at 60% of the participant's baseline PImax. Participants perform repeated forceful inspiratory breaths through the device while seated in a standardized upright position. The intervention is conducted as a single acute laboratory session and consists of one bout of inspiratory muscle resistance exercise performed until the criterion for respiratory muscle fatigue is reached.The protocol continues until the participant is unable to generate at least 90% of the baseline PImax in three consecutive maximal inspiratory efforts. This criterion is considered indicative of functional respiratory muscle fatigue. Once fatigue is confirmed, the participant immediately proceeds to the post-intervention walking assessment, during which spatiotemporal gait parameters are reassessed.The intervention is performed only once and is designed solely to induce acute, transient respiratory muscle fatigue. Therefore, it does not involve a multi-session training program or any form of long-term respiratory muscle training. Intervention Group 2 (Inactive Older Adults):The intervention in this study consists of the acute induction of respiratory muscle fatigue through inspiratory muscle resistance training using the PowerBreathe inspiratory muscle trainer. This device is an adjustable mechanical instrument that provides resistance during inspiration, allowing the training intensity to be individualized based on each participant's maximal inspiratory pressure (PImax).Prior to the intervention, each participant's maximal inspiratory pressure (PImax) is measured using a handheld mouth pressure manometer. Participants perform three maximal inspiratory efforts with one-minute rest intervals between attempts, and the highest recorded value is considered the baseline PImax.Following the determination of PImax, the resistance of the inspiratory muscle trainer is set at 60% of the participant's baseline PImax. Participants perform repeated forceful inspiratory breaths through the device while seated in a standardized upright position. The intervention is conducted as a single acute laboratory session and consists of one bout of inspiratory muscle resistance exercise performed until the criterion for respiratory muscle fatigue is reached.The protocol continues until the participant is unable to generate at least 90% of the baseline PImax in three consecutive maximal inspiratory efforts. This criterion is considered indicative of functional respiratory muscle fatigue. Once fatigue is confirmed, the participant immediately proceeds to the post-intervention walking assessment, during which spatiotemporal gait parameters are reassessed.The intervention is performed only once and is designed solely to induce acute, transient respiratory muscle fatigue. Therefore, it does not involve a multi-session training program or any form of long-term respiratory muscle training. Step length. Timepoint: Before the intervention, immediately after the intervention. Method of measurement: ZEBRIS gait analysis system. Step width. Timepoint: Before the intervention, immediately after the intervention. Method of measurement: ZEBRIS gait analysis system. Double support phase. Timepoint: Before the intervention, immediately after the intervention. Method of measurement: ZEBRIS gait analysis system. Single support phase of the right and left legs. Timepoint: Before the intervention, immediately after the intervention. Method of measurement: ZEBRIS gait analysis system. Allameh Tabataba'i University Approved 2026-04-27 Ethics committee of َAllameh Tabataba'i University Central Campus, Allameh Tabataba’i University, Olympic Village, Olympic Village Square, Tehran. tehran Tehran Iran (Islamic Republic of)