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Muscle StrengthNCT06321263

Comparison of the Effects of Peripheral Muscle Training and Inspiratory Muscle Training in Geriatric Individuals

A study testing Peripheral Muscle Training and step aerobics training and Inspiratory Muscle Training and step aerobics training in people with Muscle Strength, run by Biruni University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In geriatric individuals, there is a decrease in muscle strength, muscle mass and physical performance with ageing. These physiological changes occurring in geriatric individuals make maintaining the physical activity necessary for a healthy life difficult. Read more about this study

Who is it for?
Ages 65 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Muscle Strength
What is being tested?
Peripheral Muscle Training and step aerobics training and Inspiratory Muscle Training and step aerobics training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Mar 2024to 1 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 65 years to 80 years (Older ),
  • Standardised Mini Mental Test score ≥ 20,
  • To walk 10 meters with or without an assistive device,
  • If the participants answered No all of the questions of The Physical Activity Readiness Questionnaire
  • Volunteering to participate in the study

Who cannot join

  • With serious neurological and orthopedic problems that may prevent them from exercising,
  • With serious vision and hearing problems,
  • With a psychiatric disease,
  • With serious cardiac and pulmonary system diseases that may prevent them from exercising,
  • With vestibular system problems or medication use that may affect the vestibular system,
  • Smokers.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Buket Akıncı, Ass.Prof. contact

902124448276

bakinci@biruni.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Golden Years Life Center

    Çanakkale

    Sezen Uyanık, 0 286 21 800 18 ext. 14006, sezen.uyanik@comu.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effects of Peripheral Muscle Training and Inspiratory Muscle: Randomized Clinical Study.

In geriatric individuals, there is a decrease in muscle strength, muscle mass and physical performance with ageing. These physiological changes occurring in geriatric individuals make maintaining the physical activity necessary for a healthy life difficult. Weakness of respiratory muscles in geriatric individuals can increase the prevalence of diseases and disability. It has been shown in the literature that peripheral muscle training and inspiratory muscle training increase exercise capacity similarly. The effectiveness of moderate-intensity peripheral muscle training and inspiratory muscle training in sarcopenic geriatric individuals was compared and found to have similar effects on muscle strength.

Our study aims to compare the effects of inspiratory and peripheral muscle training in addition to aerobic exercise on muscle strength, physical performance, respiratory muscle strength, functional capacity, sarcopenia, and quality of life.

Read the detailed description

Aging causes decline in physiological systems, including the cardiorespiratory system, musculo-skeletal system, vestibulo-ocular system, slowed postural control and cognitive function (especially dual task and executive functions). These changes occurring in geriatric individuals are an increased risk factor for various diseases and affect the individual's daily living activities, working life, addiction status and communication with the environment.

The most recommended physical activity subgroups in the guidelines for geriatric individuals are aerobic exercises, strengthening exercises, flexibility exercises and balance exercises. Physiological changes that occur in the organism during the aging process can cause muscle weakness, functional losses/limitations, balance problems, cognitive problems, chronic diseases and mortality. However, physiological and mechanical respiratory changes in geriatric individuals; It is known that there is a decrease in lung elasticity, respiratory muscle strength and chest wall compliance. These physiological changes make it difficult to maintain the physical activity necessary for a healthy life. It has also been shown that weakness of respiratory muscles in geriatric individuals can increase the rate of morbidity and mortality.

It is reported in the literature that respiratory muscle training (RMT) strengthens the diaphragm in geriatric individuals and may have a protective effect against respiratory tract infections by improving aerobic capacity, physical performance and coughing skill. In addition, studies have shown that Inspiratory Muscle Training (IMT) increases the strength of the inspiratory respiratory muscles, allows a more mechanically effective breathing pattern, and provides improvements in exercise capacity, diaphragm thickness and mobility, cardiac autonomic control and functional autonomy. Studies have shown that IMT is effective and applicable in improving balance ability. It has been reported to improve dynamic and reactive balance, as well as gait speed and inspiratory muscle function in healthy geriatric individuals. Considering the stated benefits of IMT, some authors suggest that it is an alternative or complementary training method that can be used for geriatric individuals, especially when other types of exercise are not possible, and that it should be added to rehabilitation programs.

In general, it has been reported in the literature that resistant exercise training is preferred as an intervention in geriatric individuals and that this training improves muscle strength, physical performance and functional performance. In a study where a high-intensity resistance training program was applied in sarcopenic geriatric women, it was reported that it increased respiratory muscle strength and Maximum Expiratory Pressure (MEP) and affected health-related quality of life.

There are opinions reported in the literature that improvement in peripheral and inspiratory muscle strength will reduce the risk of mortality. The effects of moderate-intensity peripheral muscle training and inspiratory muscle training were compared in sarcopenic geriatric individuals and were found to have similar effects on muscle strength. It has been reported that there is no significant change in muscle mass and physical performance. However, no study has been found in which the aerobic and strengthening exercises recommended for geriatric individuals are combined. In order to shed light on this deficiency in the literature, the investigators aim in our study to compare the effects of peripheral muscle training and inspiratory muscle training combined with aerobic training on muscle strength, physical performance, functional capacity and quality of life.

Conditions
Muscle Strength
Being tested
Peripheral Muscle Training and step aerobics training, Inspiratory Muscle Training and step aerobics training
Keywords
Muscle strength, Physical performance, Respiratory muscle strength, Functional capacity, Quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peripheral Muscle Training and step aerobics trainingOther

    Also called Peripheral Muscle Training

    First 5-minute warm-up in the protocol (calisthenic exercises); 30-40 minutes of resistance exercises and step aerobic exercises and the last 5 minutes cooling (stretching exercises) period will be applied.

  • Inspiratory Muscle Training and step aerobics trainingOther

    Also called Inspiratory Muscle Training

    First 5-minute warm-up in the protocol (calisthenic exercises); 30-40 minutes of resistance exercises and step aerobic exercises and the last 5 minutes cooling (stretching exercises) period will be applied.

Study groups in NCT06321263
Study groupRoleWhat they receive
Peripheral Muscle Training GroupExperimentalOlder individuals in this group will participate in group exercise training, including aerobic and resistance training, twice a week for ten weeks, each session supervised by a researcher physiotherapist and lasting one hour.
Receives: Other: Peripheral Muscle Training and step aerobics training
Inspiratory Muscle Training Group:ExperimentalOlder people in this group will perform aerobic and resistance training for 1 hour a day, twice a week for ten weeks, under the supervision of a researcher physiotherapist. As for Inspiratory Muscle Training, they will participate in training with 30 breathing cycles a day, six days a week, for ten weeks (two days in the clinic, four days at home).
Receives: Other: Inspiratory Muscle Training and step aerobics training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The sociodemographic data form

    Socio-demographic data of individuals (name-surname, age, gender, height,weight, smoking, occupation, education) will be collected with the demographic data collection form created by the researchers. In the clinical information section, other diseases and medications used will be recorded.

    Measured: Ten weeks

  2. Hand grip strength

    Three consecutive measurements will be made on the dominant hand with a Jamar hand dynamometer, 1 minute apart, and the highest value will be recorded.

    Measured: Ten weeks

  3. Maximal inspiratory and expiratory pressures (MIP, MEP)

    Static inspiratory (MIP) or expiratory (MEP) mouth pressures assess respiratory muscle strength.

    Measured: Ten weeks

  4. 6-Minute Walk Test (6MWT)

    The 6MWT will be used to measure functional capacity.

    Measured: Ten weeks

  5. The Short Physical Performance Battery (SPPB)

    SPPB is a set of tests that combine gait speed, chair stand, and balance measures. It is used to predict possible disability and monitor function in older individuals.

    Measured: Ten weeks

  6. Assessment of seniors᾽ quality of life: WHOQOL-OLD questionnaire

    WHOQOL-OLD, a 24-item QOL measure, was developed by the WHOQOL Group as an add-on module to their QOL measures, specifically for use with older adults. A total score is the mean of the summed facet scores and ranges from one to five, with higher scores indicating better QOL.

    Measured: Ten weeks

Secondary outcomes (1)
  1. SARC-F questionnaire

    It is a rapid diagnostic test developed for sarcopenia. A SARC-F survey score ≥ 4 is important for the diagnosis of sarcopenia. SARC-F score range is from 0 to 10; 0-3 points represent healthy condition, 4 points and above represent symptomatic condition.

    Measured: Ten weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2024
  2. Study start25 Mar 2024
  3. Primary completion27 Sep 2024
  4. Study completion1 Jun 2025 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06321263
Sponsor's protocol ID
798307
Status last verified
May 2025
First submitted
14 Mar 2024
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

    PubMed 12091180
  • 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 31978126
  • Flor-Rufino C, Barrachina-Igual J, Perez-Ros P, Pablos-Monzo A, Martinez-Arnau FM. Resistance training of peripheral muscles benefits respiratory parameters in older women with sarcopenia: Randomized controlled trial. Arch Gerontol Geriatr. 2023 Jan;104:104799. doi: 10.1016/j.archger.2022.104799. Epub 2022 Aug 29.

    PubMed 36070636
  • Hallage T, Krause MP, Haile L, Miculis CP, Nagle EF, Reis RS, Da Silva SG. The effects of 12 weeks of step aerobics training on functional fitness of elderly women. J Strength Cond Res. 2010 Aug;24(8):2261-6. doi: 10.1519/JSC.0b013e3181ddacc6.

    PubMed 20634751
  • Cebria I Iranzo MA, Balasch-Bernat M, Tortosa-Chulia MA, Balasch-Parisi S. Effects of Resistance Training of Peripheral Muscles Versus Respiratory Muscles in Older Adults With Sarcopenia Who are Institutionalized: A Randomized Controlled Trial. J Aging Phys Act. 2018 Oct 1;26(4):637-646. doi: 10.1123/japa.2017-0268. Epub 2018 Aug 27.

    PubMed 29431561
  • Joung HJ, Lee Y. Effect of Creative Dance on Fitness, Functional Balance, and Mobility Control in the Elderly. Gerontology. 2019;65(5):537-546. doi: 10.1159/000499402. Epub 2019 May 3.

    PubMed 31055579
  • Kalapotharakos VI, Diamantopoulos K, Tokmakidis SP. Effects of resistance training and detraining on muscle strength and functional performance of older adults aged 80 to 88 years. Aging Clin Exp Res. 2010 Apr;22(2):134-40. doi: 10.1007/BF03324786.

    PubMed 20440099
  • Kim SH, Shin MJ, Lee JM, Huh S, Shin YB. Effects of a new respiratory muscle training device in community-dwelling elderly men: an open-label, randomized, non-inferiority trial. BMC Geriatr. 2022 Feb 24;22(1):155. doi: 10.1186/s12877-022-02828-8.

    PubMed 35209851
  • Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.

    PubMed 30956204
  • Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.

    PubMed 23810110
  • Power M, Quinn K, Schmidt S; WHOQOL-OLD Group. Development of the WHOQOL-old module. Qual Life Res. 2005 Dec;14(10):2197-214. doi: 10.1007/s11136-005-7380-9.

    PubMed 16328900
  • Puthoff ML. Outcome measures in cardiopulmonary physical therapy: short physical performance battery. Cardiopulm Phys Ther J. 2008 Mar;19(1):17-22. No abstract available.

    PubMed 20467494
  • Segev-Jacubovski O, Herman T, Yogev-Seligmann G, Mirelman A, Giladi N, Hausdorff JM. The interplay between gait, falls and cognition: can cognitive therapy reduce fall risk? Expert Rev Neurother. 2011 Jul;11(7):1057-75. doi: 10.1586/ern.11.69.

    PubMed 21721921
  • Seixas MB, Almeida LB, Trevizan PF, Martinez DG, Laterza MC, Vanderlei LCM, Silva LP. Effects of Inspiratory Muscle Training in Older Adults. Respir Care. 2020 Apr;65(4):535-544. doi: 10.4187/respcare.06945. Epub 2019 Oct 29.

    PubMed 31662444
  • Woo J, Leung J, Morley JE. Validating the SARC-F: a suitable community screening tool for sarcopenia? J Am Med Dir Assoc. 2014 Sep;15(9):630-4. doi: 10.1016/j.jamda.2014.04.021. Epub 2014 Jun 16.

    PubMed 24947762

Questions about this trial

What is this clinical trial studying?

A study testing Peripheral Muscle Training and step aerobics training and Inspiratory Muscle Training and step aerobics training in people with Muscle Strength, run by Biruni University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Buket Akıncı, Ass.Prof. (902124448276, bakinci@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The sociodemographic data form (time frame: Ten weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06321263, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

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