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:
Acibadem University
Organization:
Study Overview
Official Title:
Comparative Effects of Balance and Inspiratory Muscle Training on Balance, Respiratory Muscle Strength, and Physical Performance in Older Adults: A Randomized Comparative Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Participants aged 60 and over will be randomly assigned to one of three groups:
Respiratory Muscle Training group (30 breaths, twice daily),
Balance Training group (45-50 minute sessions, 3 days a week),
Combined Training group (both IMT and balance exercises).
The 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.
Participants aged 60 and over will be randomly assigned to one of three groups:
Respiratory Muscle Training group (30 breaths, twice daily),
Balance Training group (45-50 minute sessions, 3 days a week),
Combined Training group (both IMT and balance exercises).
The 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.
Detailed Description:
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.
Methodology and Interventions:
Participants 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):
Group 1 (IMT): Participants will perform 30 breaths twice daily using an IMT device for 8 weeks.
Group 2 (Balance): Participants will attend 45-50 minute supervised balance training sessions, 3 days per week for 8 weeks.
Group 3 (Combined): Participants will perform both the daily IMT protocol and the thrice-weekly balance sessions.
Evaluation Criteria:
Outcomes 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.
Data 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.
Methodology and Interventions:
Participants 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):
Group 1 (IMT): Participants will perform 30 breaths twice daily using an IMT device for 8 weeks.
Group 2 (Balance): Participants will attend 45-50 minute supervised balance training sessions, 3 days per week for 8 weeks.
Group 3 (Combined): Participants will perform both the daily IMT protocol and the thrice-weekly balance sessions.
Evaluation Criteria:
Outcomes 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.
Data 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: