NCT05875597

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 2, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

May 25, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

May 16, 2023

Last Update Submit

May 24, 2023

Conditions

Resistance TrainingAgedNursing HomesSarcopenia

Outcome Measures

Primary Outcomes (4)

  • Changes in handgrip strength

    Hand-held dynamometer JAMAR

    12 weeks

  • Changes in muscle mass

    electrical bioimpedance

    12 weeks

  • Changes in physical performance

    SPPB test battery

    12 weeks

  • Changes in Funcional Mobility

    Measured by the Timed Up and Go test (TUG)

    12 weeks

Secondary Outcomes (2)

  • Changes in Risk of falling

    12 weeks

  • Changes in Health-Related Quality of Life

    12 weeks

Study Arms (2)

Experimental Group Exercise

EXPERIMENTAL

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

Other: Physical therapy exercise programme

Control Group

NO INTERVENTION

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

Interventions

Physical therapy exercise programmeOTHER

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

Experimental Group Exercise

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rosalba Nursing Home

Mérida, Badajoz, Spain

RECRUITING

Related Publications (8)

  • 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.

    PMID: 26707544BACKGROUND

  • 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.

    PMID: 21877007BACKGROUND

  • 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.

    PMID: 21527165BACKGROUND

  • 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.

    PMID: 28452077BACKGROUND

  • 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.

    PMID: 17291986BACKGROUND

  • 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.

    PMID: 20200012BACKGROUND

  • 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.

    PMID: 26350943BACKGROUND

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

    PMID: 23575205BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Luis Espejo Antúnez

    Universidad de Extremadura

    STUDY DIRECTOR

Central Study Contacts

Luis Espejo Antunez

CONTACT

650057024luisea@unex.es

Luis Espejo Antúnez

CONTACT

650057024luisea@unex.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Physical Therapy

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

March 2, 2023

Primary Completion

May 30, 2023

Study Completion

October 30, 2023

Last Updated

May 25, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)