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

Primary Purpose

Resistance Training, Aged, Nursing Homes

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical therapy exercise programme
Sponsored by
University of Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resistance Training

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Rosalba Nursing HomeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group Exercise

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in handgrip strength
Hand-held dynamometer JAMAR
Changes in muscle mass
electrical bioimpedance
Changes in physical performance
SPPB test battery
Changes in Funcional Mobility
Measured by the Timed Up and Go test (TUG)

Secondary Outcome Measures

Changes in Risk of falling
The Downton, Tinetti fall risk index was used to assess the risk of falling.
Changes in Health-Related Quality of Life
Will be measured through the SF-12 health questionnaire.

Full Information

First Posted
May 16, 2023
Last Updated
May 24, 2023
Sponsor
University of Extremadura
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1. Study Identification

Unique Protocol Identification Number
NCT05875597
Brief Title
Detection of Clinical-functional Changes Following Exercise Therapy and Neuroscience Education in Institutionalised and Community-dwelling Older Adults Diagnosed With Sarcopenia
Official Title
Detection of Clinical-functional Changes Following Exercise Therapy and Education in Institutionalised and Community-dwelling Older Adults Diagnosed With Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Extremadura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistance Training, Aged, Nursing Homes, Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group Exercise
Arm Type
Experimental
Arm Description
Participants will be required to undertake a strength oriented physical therapy exercise programme.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will not engage in a strength oriented therapeutic physical exercise programme.
Intervention Type
Other
Intervention Name(s)
Physical therapy exercise programme
Intervention Description
Carrying out a programme of therapeutic physical exercise for 12 weeks, twice a week for 45 minutes.
Primary Outcome Measure Information:
Title
Changes in handgrip strength
Description
Hand-held dynamometer JAMAR
Time Frame
12 weeks
Title
Changes in muscle mass
Description
electrical bioimpedance
Time Frame
12 weeks
Title
Changes in physical performance
Description
SPPB test battery
Time Frame
12 weeks
Title
Changes in Funcional Mobility
Description
Measured by the Timed Up and Go test (TUG)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in Risk of falling
Description
The Downton, Tinetti fall risk index was used to assess the risk of falling.
Time Frame
12 weeks
Title
Changes in Health-Related Quality of Life
Description
Will be measured through the SF-12 health questionnaire.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Espejo Antunez
Phone
650057024
Email
luisea@unex.es
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Espejo Antúnez
Phone
650057024
Email
luisea@unex.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Espejo Antúnez
Organizational Affiliation
Universidad de Extremadura
Official's Role
Study Director
Facility Information:
Facility Name
Rosalba Nursing Home
City
Mérida
State/Province
Badajoz
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Espejo Antunez
Phone
650057024
Email
luisea@unex.es
First Name & Middle Initial & Last Name & Degree
Luis Espejo Antúnez
Phone
650057024
Email
luisea@unex.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26707544
Citation
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.
Results Reference
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PubMed Identifier
21877007
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.
Results Reference
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PubMed Identifier
21527165
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.
Results Reference
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PubMed Identifier
28452077
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
20200012
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Citation
Cederholm T, Cruz-Jentoft AJ, Maggi S. Sarcopenia and fragility fractures. Eur J Phys Rehabil Med. 2013 Feb;49(1):111-7.
Results Reference
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Detection of Clinical-functional Changes Following Exercise Therapy and Neuroscience Education in Institutionalised and Community-dwelling Older Adults Diagnosed With Sarcopenia

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