NCT06321263

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

March 14, 2024

Last Update Submit

May 24, 2025

Conditions

Keywords

Muscle strengthPhysical performanceRespiratory muscle strengthFunctional capacityQuality of life

Outcome Measures

Primary Outcomes (6)

  • 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.

    Ten weeks

  • 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.

    Ten weeks

  • Maximal inspiratory and expiratory pressures (MIP, MEP)

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

    Ten weeks

  • 6-Minute Walk Test (6MWT)

    The 6MWT will be used to measure functional capacity.

    Ten weeks

  • 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.

    Ten weeks

  • 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.

    Ten weeks

Secondary Outcomes (1)

  • SARC-F questionnaire

    Ten weeks

Other Outcomes (1)

  • Canadian Occupational Performance Measure

    Ten weeks

Study Arms (2)

Peripheral Muscle Training Group

EXPERIMENTAL

Older 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.

Other: Peripheral Muscle Training and step aerobics training

Inspiratory Muscle Training Group:

EXPERIMENTAL

Older 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).

Other: Inspiratory Muscle Training and step aerobics training

Interventions

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.

Also known as: Peripheral Muscle Training
Peripheral Muscle Training Group

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.

Also known as: Inspiratory Muscle Training
Inspiratory Muscle Training Group:

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golden Years Life Center

Çanakkale, Turkey (Türkiye)

RECRUITING

Related Publications (15)

  • 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.

    PMID: 12091180BACKGROUND
  • 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: 31978126BACKGROUND
  • 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.

    PMID: 36070636BACKGROUND
  • 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.

    PMID: 20634751BACKGROUND
  • 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.

    PMID: 29431561BACKGROUND
  • 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.

    PMID: 31055579BACKGROUND
  • 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.

    PMID: 20440099BACKGROUND
  • 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.

    PMID: 35209851BACKGROUND
  • 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.

    PMID: 30956204BACKGROUND
  • 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.

    PMID: 23810110BACKGROUND
  • 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.

    PMID: 16328900BACKGROUND
  • 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.

    PMID: 20467494BACKGROUND
  • 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.

    PMID: 21721921BACKGROUND
  • 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.

    PMID: 31662444BACKGROUND
  • 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.

    PMID: 24947762BACKGROUND

Study Officials

  • Buket Akıncı, Ass.Prof.

    Biruni University

    STUDY DIRECTOR
  • Sezen Uyanık, MSc

    Çanakkale Onsekiz Mart University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Buket Akıncı, Ass.Prof.

CONTACT

Sezen Uyanık, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 14, 2024

First Posted

March 20, 2024

Study Start

March 25, 2024

Primary Completion

September 27, 2024

Study Completion

June 1, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations