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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

Sponsor
University of Extremadura (Other)
Overall Status
Recruiting
CT.gov ID
NCT05875597
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physical therapy exercise programme
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Detection of Clinical-functional Changes Following Exercise Therapy and Education in Institutionalised and Community-dwelling Older Adults Diagnosed With Sarcopenia
Actual Study Start Date :
Mar 2, 2023
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group Exercise

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

Other: Physical therapy exercise programme
Carrying out a programme of therapeutic physical exercise for 12 weeks, twice a week for 45 minutes.
No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

  1. Changes in handgrip strength [12 weeks]

    Hand-held dynamometer JAMAR

  2. Changes in muscle mass [12 weeks]

    electrical bioimpedance

  3. Changes in physical performance [12 weeks]

    SPPB test battery

  4. Changes in Funcional Mobility [12 weeks]

    Measured by the Timed Up and Go test (TUG)

Secondary Outcome Measures

  1. Changes in Risk of falling [12 weeks]

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

  2. Changes in Health-Related Quality of Life [12 weeks]

    Will be measured through the SF-12 health questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rosalba Nursing Home Mérida Badajoz Spain

Sponsors and Collaborators

  • University of Extremadura

Investigators

  • Study Director: Luis Espejo Antúnez, Universidad de Extremadura

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Luis Espejo Antunez, Ph.D. Physical Therapy, University of Extremadura
ClinicalTrials.gov Identifier:
NCT05875597
Other Study ID Numbers:
  • LEAntunez
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sarcopenia

Study Results

No Results Posted as of May 25, 2023