Comparative Effects of Balance and Inspiratory Muscle Training in Older Adults

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

Overview

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.

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.

Interventions

• Device Inspiratory Muscle Training
  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.
• Behavioral Balance Training
  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.

Primary outcome measures

• Maximal Inspiratory Pressure (MIP) [Time frame: Baseline and 8 weeks.]
• Maximal Expiratory Pressure (MEP) [Time frame: Baseline and 8 weeks.]
• Timed Up and Go (TUG) Test [Time frame: Baseline and 8 weeks.]
• Respiratory Muscle Endurance (Incremental Threshold Loading Test) [Time frame: Baseline and 8 weeks.]
• Single Leg Stance Test (SLST) [Time frame: Baseline and 8 weeks.]
• 6-Minute Walk Test (6MWT) [Time frame: Baseline and 8 weeks.]
• Core Muscle Endurance Test [Time frame: Baseline and 8 weeks.]

Secondary outcome measures (8)

• Short Physical Performance Battery (SPPB) [Time frame: Baseline and 8 weeks.]
• Charlson Comorbidity Index (CCI) [Time frame: Baseline.]
• Mini-Mental State Examination (MMSE) [Time frame: Baseline.]
• Montreal Cognitive Assessment (MoCA) [Time frame: Baseline.]
• Tinetti Performance-Oriented Mobility Assessment (POMA) [Time frame: Baseline and 8 weeks.]
• Handgrip Strength [Time frame: Baseline and 8 weeks.]
• Physical Activity Scale for the Elderly (PASE) [Time frame: Baseline.]
• Fatigue Impact Scale (FIS) [Time frame: Baseline.]

Eligibility criteria

Inclusion criteria

• Aged 60 years or older.
• Mini-Mental State Examination (MMSE) score of 22 or higher.
• Ability to walk 10 meters independently without human assistance.
• Ability to read and write.
• Volunteering to participate and providing written informed consent.

Exclusion criteria

• Current use of sedative or hypnotic medications.
• 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.
• Presence of clinically significant cardiovascular or pulmonary complications (e.g., COPD, active lung disease, or uncontrolled hypertension).
• Severe postural abnormalities that may interfere with the study (e.g., advanced scoliosis or kyphosis).
• Acute or chronic orthopedic conditions preventing participation in a balance exercise program (e.g., lower extremity fractures or severe joint instability).
• High risk of sarcopenia, defined as a SARC-F score of 4 or higher.
• Significant communication or cognitive barriers that prevent following the exercise instructions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Darülaceze Müdürlüğü — Istanbul

Publications

• 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 31978126
• 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 34530401
• 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 29549494
• 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 23835773
• 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. PMID 27384328

Identifiers

NCT: NCT07468968 · 2025-03-17.12.2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗