GeriatricNCT07468968
Comparative Effects of Balance and Inspiratory Muscle Training in Older Adults
A study testing Inspiratory Muscle Training and Balance Training in people with Geriatric and Geriatrics Rehabilitation, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geriatric, Geriatrics Rehabilitation, Geriatric Fall
- What is being tested?
- Inspiratory Muscle Training and Balance Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2026to 10 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
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.
Read the 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.
- Conditions
- Geriatric, Geriatrics Rehabilitation, Geriatric Fall, Geriatric Health
- Being tested
- Inspiratory Muscle Training, Balance Training
- Keywords
- geriatrics, balance, respiratory muscle strength, functional capacity, fall risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingDevice
Also called Threshold IMT, Respiratory 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.
Balance TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Inspiratory Muscle Training; Behavioral: Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks.
Secondary outcomes (8)
Short Physical Performance Battery (SPPB)
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.
Measured: Baseline and 8 weeks.
Charlson Comorbidity Index (CCI)
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.
Measured: Baseline.
Mini-Mental State Examination (MMSE)
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.
Measured: Baseline.
Montreal Cognitive Assessment (MoCA)
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.
Measured: Baseline.
Tinetti Performance-Oriented Mobility Assessment (POMA)
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.
Measured: Baseline and 8 weeks.
Handgrip Strength
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.
Measured: Baseline and 8 weeks.
Physical Activity Scale for the Elderly (PASE)
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.
Measured: Baseline.
Fatigue Impact Scale (FIS)
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.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start12 Mar 2026
- Primary completion12 Nov 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GeriatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University
- Responsible party
- Principal investigator, Ozge Hakli, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468968
- Sponsor's protocol ID
- 2025-03-17.12.2025
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31978126Ferraro 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.
PubMed 34530401Rodrigues 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.
PubMed 29549494Cebria 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.
PubMed 23835773Pessoa 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.
PubMed 27384328