Detection of Clinical-functional Changes Following Exercise Therapy and Neuroscience Education in Institutionalised and Community-dwelling Older Adults Diagnosed With Sarcopenia

NCT ID: NCT05875597

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-02

Study Completion Date

2023-10-30

Brief Summary

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Nowadays, ageing is an important aspect to consider from a social, healthcare and economic perspective. For this reason, it is necessary to focus on all the elements which can help staying healthy and active in old age. Physical activity and exercise are one of these, and more specifically resistance training.

Detailed Description

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Recently, it is been evidenced that physical activity and exercise are an important coping strategy to get what is called "active ageing". However, it is still under discussion some key aspect, like the training type or the optimal dose, among others. There is a modality of resistance training which it has not been sufficiently studied in old age population: the high intensity interval training. It has been demonstrated in other population (like cardiovascular patients or cancer survivor patients) that this modality of training can improve a lots their physical condition. Furthermore, it produces a higher adhesion to the training program, because it does not require so long time like another type of training. For this reason, the aim of this investigation is to assess how implement this modality of training on elderly people with sarcopenia.

Conditions

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Resistance Training Aged Nursing Homes Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental Group Exercise

Participants will be required to undertake a strength oriented physical therapy exercise programme.

Group Type EXPERIMENTAL

Physical therapy exercise programme

Intervention Type OTHER

Carrying out a programme of therapeutic physical exercise for 12 weeks, twice a week for 45 minutes.

Control Group

Participants will not engage in a strength oriented therapeutic physical exercise programme.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical therapy exercise programme

Carrying out a programme of therapeutic physical exercise for 12 weeks, twice a week for 45 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Older adults aged 55 years or older.
* Living in an institutionalised setting or community-dwelling older adults living in the province of Badajoz or Cáceres.
* Voluntarily participating in the study.
* Who had a diagnosis of sarcopenia/fragility in the last year.
* Submit a prescription from the centre's medical practitioner to participate in the study as physiotherapy intervention would be appropriate and potentially beneficial.

Exclusion Criteria

* Patients with cognitive impairment (score ≥24 in the validated Spanish version for general older adults of the Mini-Mental Status Examination).
* Unable to tolerate moderate physical activity due to cardiovascular or respiratory disease.
* With balance disorders other than those caused by ageing such as dizziness or vestibular disorders requiring the ingestion of medication with a potential effect on balance, as well as balance disorders secondary to the ingestion of any medication or other medical causes.
* At high risk of falling (≥ 51 points on the MORSE scale).
* At high risk of falling (≥ 51 points on the MORSE scale).
* At high risk of falling (≥ 51 points on the MORSE scale).
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Extremadura

OTHER

Sponsor Role lead

Responsible Party

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Luis Espejo Antunez

Ph.D. Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luis Espejo Antúnez

Role: STUDY_DIRECTOR

Universidad de Extremadura

Locations

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Rosalba Nursing Home

Mérida, Badajoz, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Luis Espejo Antunez

Role: CONTACT

650057024

Luis Espejo Antúnez

Role: CONTACT

650057024

Facility Contacts

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Luis Espejo Antunez

Role: primary

650057024

Luis Espejo Antúnez

Role: backup

650057024

References

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Benavent-Caballer V, Sendin-Magdalena A, Lison JF, Rosado-Calatayud P, Amer-Cuenca JJ, Salvador-Coloma P, Segura-Orti E. Physical factors underlying the Timed "Up and Go" test in older adults. Geriatr Nurs. 2016 Mar-Apr;37(2):122-7. doi: 10.1016/j.gerinurse.2015.11.002. Epub 2015 Dec 17.

Reference Type BACKGROUND
PMID: 26707544 (View on PubMed)

Pagotto V, Nakatani AY, Silveira EA. [Factors associated with poor self-rated health in elderly users of the Brazilian Unified National Health System]. Cad Saude Publica. 2011 Aug;27(8):1593-602. doi: 10.1590/s0102-311x2011000800014. Portuguese.

Reference Type BACKGROUND
PMID: 21877007 (View on PubMed)

Fielding RA, Vellas B, Evans WJ, Bhasin S, Morley JE, Newman AB, Abellan van Kan G, Andrieu S, Bauer J, Breuille D, Cederholm T, Chandler J, De Meynard C, Donini L, Harris T, Kannt A, Keime Guibert F, Onder G, Papanicolaou D, Rolland Y, Rooks D, Sieber C, Souhami E, Verlaan S, Zamboni M. Sarcopenia: an undiagnosed condition in older adults. Current consensus definition: prevalence, etiology, and consequences. International working group on sarcopenia. J Am Med Dir Assoc. 2011 May;12(4):249-56. doi: 10.1016/j.jamda.2011.01.003. Epub 2011 Mar 4.

Reference Type BACKGROUND
PMID: 21527165 (View on PubMed)

Brocca L, McPhee JS, Longa E, Canepari M, Seynnes O, De Vito G, Pellegrino MA, Narici M, Bottinelli R. Structure and function of human muscle fibres and muscle proteome in physically active older men. J Physiol. 2017 Jul 15;595(14):4823-4844. doi: 10.1113/JP274148. Epub 2017 Jun 5.

Reference Type BACKGROUND
PMID: 28452077 (View on PubMed)

Servais S, Letexier D, Favier R, Duchamp C, Desplanches D. Prevention of unloading-induced atrophy by vitamin E supplementation: links between oxidative stress and soleus muscle proteolysis? Free Radic Biol Med. 2007 Mar 1;42(5):627-35. doi: 10.1016/j.freeradbiomed.2006.12.001. Epub 2006 Dec 15.

Reference Type BACKGROUND
PMID: 17291986 (View on PubMed)

Narici MV, Maffulli N. Sarcopenia: characteristics, mechanisms and functional significance. Br Med Bull. 2010;95:139-59. doi: 10.1093/bmb/ldq008. Epub 2010 Mar 2.

Reference Type BACKGROUND
PMID: 20200012 (View on PubMed)

Dietzel R, Felsenberg D, Armbrecht G. Mechanography performance tests and their association with sarcopenia, falls and impairment in the activities of daily living - a pilot cross-sectional study in 293 older adults. J Musculoskelet Neuronal Interact. 2015 Sep;15(3):249-56.

Reference Type BACKGROUND
PMID: 26350943 (View on PubMed)

Cederholm T, Cruz-Jentoft AJ, Maggi S. Sarcopenia and fragility fractures. Eur J Phys Rehabil Med. 2013 Feb;49(1):111-7.

Reference Type BACKGROUND
PMID: 23575205 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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LEAntunez

Identifier Type: -

Identifier Source: org_study_id

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