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

May 24, 2023 updated by: Luis Espejo Antunez, University of Extremadura

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Luis Espejo Antúnez
  • Phone Number: 650057024
  • Email: luisea@unex.es

Study Locations

  • Spain
    • Badajoz
      • Mérida, Badajoz, Spain
        • Recruiting
        • Rosalba Nursing Home
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in handgrip strength
Time Frame: 12 weeks
Hand-held dynamometer JAMAR
12 weeks
Changes in muscle mass
Time Frame: 12 weeks
electrical bioimpedance
12 weeks
Changes in physical performance
Time Frame: 12 weeks
SPPB test battery
12 weeks
Changes in Funcional Mobility
Time Frame: 12 weeks
Measured by the Timed Up and Go test (TUG)
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Extremadura

Investigators

  • Study Director: Luis Espejo Antúnez, Universidad de Extremadura

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2023

Primary Completion (Estimated)

May 30, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEAntunez

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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