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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875597
• Other study ID #: LEAntunez
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: February 2023
• Source: University of Extremadura
• Contact: Luis Espejo Antunez
• Phone: 650057024
• Email: luisea[@]unex.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aged
• Nursing Homes
• Resistance Training
• Sarcopenia

Intervention

Other:
• Physical therapy exercise programme
Carrying out a programme of therapeutic physical exercise for 12 weeks, twice a week for 45 minutes.

Locations

Country	Name	City	State
Spain	Rosalba Nursing Home	Mérida	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
University of Extremadura

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in handgrip strength	Hand-held dynamometer JAMAR	12 weeks
Primary	Changes in muscle mass	electrical bioimpedance	12 weeks
Primary	Changes in physical performance	SPPB test battery	12 weeks
Primary	Changes in Funcional Mobility	Measured by the Timed Up and Go test (TUG)	12 weeks
Secondary	Changes in Risk of falling	The Downton, Tinetti fall risk index was used to assess the risk of falling.	12 weeks
Secondary	Changes in Health-Related Quality of Life	Will be measured through the SF-12 health questionnaire.	12 weeks