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Resistance TrainingNCT05875597

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

A study testing Physical therapy exercise programme in people with Resistance Training and Aged, run by University of Extremadura at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Resistance Training, Aged, Nursing Homes
What is being tested?
Physical therapy exercise programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
2 Mar 2023to 30 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Luis Espejo Antunez contact

650057024

luisea@unex.es

Luis Espejo Antúnez contact

650057024

luisea@unex.es

Spain1 site, 1 recruiting

  • Rosalba Nursing Home

    Mérida, Badajoz

    Luis Espejo Antunez, 650057024, luisea@unex.es

    Luis Espejo Antúnez, 650057024, luisea@unex.es

    Recruiting

Other trials in Spain

About this study

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

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.

Read the detailed description

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.

Being tested
Physical therapy exercise programme
Medical subject headings
Sarcopenia

What participants receive

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

  • Physical therapy exercise programmeOther

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

Study groups in NCT05875597
Study groupRoleWhat they receive
Experimental Group ExerciseExperimentalParticipants will be required to undertake a strength oriented physical therapy exercise programme.
Receives: Other: Physical therapy exercise programme
Control GroupNo interventionParticipants will not engage in a strength oriented therapeutic physical exercise programme.

What is being measured

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

  1. Changes in handgrip strength

    Hand-held dynamometer JAMAR

    Measured: 12 weeks

  2. Changes in muscle mass

    electrical bioimpedance

    Measured: 12 weeks

  3. Changes in physical performance

    SPPB test battery

    Measured: 12 weeks

  4. Changes in Funcional Mobility

    Measured by the Timed Up and Go test (TUG)

    Measured: 12 weeks

Secondary outcomes (2)

  1. Changes in Risk of falling

    The Downton, Tinetti fall risk index was used to assess the risk of falling.

    Measured: 12 weeks

  2. Changes in Health-Related Quality of Life

    Will be measured through the SF-12 health questionnaire.

    Measured: 12 weeks

Timeline

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

  1. First posted25 May 2023
  2. Study start2 Mar 2023
  3. Primary completion30 May 2023 (estimated)
  4. Study completion30 Oct 2023 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05875597
Sponsor's protocol ID
LEAntunez
Status last verified
Feb 2023
First submitted
16 May 2023
Last updated
25 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26707544

  • 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.

    PubMed 21877007

  • 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.

    PubMed 21527165

  • 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.

    PubMed 28452077

  • 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.

    PubMed 17291986

  • 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.

    PubMed 20200012

  • 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.

    PubMed 26350943

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

    PubMed 23575205

Questions about this trial

What is this clinical trial studying?

A study testing Physical therapy exercise programme in people with Resistance Training and Aged, run by University of Extremadura at 1 site in Spain.

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: status not confirmed, as of the sponsor's last update on 25 May 2023. 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 Spain. 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?

Results are not available in the source record.

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

Contact Luis Espejo Antunez (650057024, luisea@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in handgrip strength (time frame: 12 weeks). The study lists 4 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 NCT05875597, which also lists 8 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 25 May 2023.

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