Comparative Effects of Balance and Inspiratory Muscle Training in Older Adults

NCT07468968 | Enrolling By Invitation

• 1 other identifier: 2025-03-17.12.2025
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Geriatric; Geriatrics Rehabilitation; Geriatric Fall; Geriatric Health

Keywords

geriatrics; balance; respiratory muscle strength; functional capacity; fall risk

Outcome Measures

Primary Outcomes (7)

• Maximal Inspiratory Pressure (MIP)

  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.

  Baseline and 8 weeks.

• Maximal Expiratory Pressure (MEP)

  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.

  Baseline and 8 weeks.

• Timed Up and Go (TUG) Test

  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.

  Baseline and 8 weeks.

• Respiratory Muscle Endurance (Incremental Threshold Loading Test)

  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.

  Baseline and 8 weeks.

• Single Leg Stance Test (SLST)

  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.

  Baseline and 8 weeks.

• 6-Minute Walk Test (6MWT)

  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.

  Baseline and 8 weeks.

• Core Muscle Endurance Test

  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.

  Baseline and 8 weeks.

Secondary Outcomes (8)

• Short Physical Performance Battery (SPPB)

  Baseline and 8 weeks.

• Charlson Comorbidity Index (CCI)

  Baseline.

• Mini-Mental State Examination (MMSE)

  Baseline.

• Montreal Cognitive Assessment (MoCA)

  Baseline.

• Tinetti Performance-Oriented Mobility Assessment (POMA)

  Baseline and 8 weeks.

Study Arms (3)

Inspiratory Muscle Training

EXPERIMENTAL

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.

Device: Inspiratory Muscle Training

Balance Training

EXPERIMENTAL

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.

Behavioral: Balance Training

Combined Training Group (IMT + Balance)

EXPERIMENTAL

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.

Device: Inspiratory Muscle Training; Behavioral: Balance Training

Interventions

Inspiratory Muscle Training DEVICE

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.

Also known as: Threshold IMT, Respiratory Muscle Training.

Combined Training Group (IMT + Balance); Inspiratory Muscle Training

Balance Training BEHAVIORAL

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.

Balance Training; Combined Training Group (IMT + Balance)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acibadem University: lead
• Biruni University: collaborator

Study Sites (1)

Darülaceze Müdürlüğü

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)