Clinical trial NCT02120586: Preventive Physiotherapy Intervention in Elderly People With Sarcopenia
Official title: Effects and Costs of Preventive Physiotherapy Intervention in Institutionalized Elderly People With Sarcopenia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Syndrome; Institutionalization
Keywords: Elderly
Institutionalization
Sarcopenia
Strength training
Muscle mass
Muscle strength
Physical performance
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 91
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates two strength training protocols (one in peripheral muscles and one in inspiratory muscles) in the improvement of skeletal muscle mass and function in institutionalized elderly with sarcopenia. Participants will be assigned randomly in a control or one of both experimental groups.

Detailed description: Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life and death (Goodpaster et al, 2006; Delmonico et al, 2007). The contributing factors are those related to aging process, non-optimal diet, bed rest or sedentary lifestyle, chronic diseases and certain drug treatments. Most of these factors are present in the older population with comorbidity, frequently institutionalized to receive a professional long-term care.

Since the European Working Group on Sarcopenia in Older People (Cruz-Jentoft et al, 2010) recommends using the presence of both low muscle mass and low muscle function (strength and/or physical performance) for the diagnosis of sarcopenia, interventions should be focused in both criteria. The aim of this study is to prevent loss of skeletal muscle mass and strength in institutionalized elderly with sarcopenia.

To this purpose, the investigators study undertakes two physiotherapy interventions to preventing/treating Sarcopenia, namely, maintenance of muscle mass and improvement of strength in peripheral and respiratory muscles. Both interventions are common in the following features: supervision, duration, frequency and intensity of the training program.

The primary outcomes are those related to muscle mass and strength. Secondary outcomes will be related to muscle function (muscle endurance and/or physical performance), costs and health status (number of falls and fractures, exacerbations of chronic diseases, hospitalizations and deaths during the year after concluding the physiotherapy interventions).

Eligibility criteria: Inclusion Criteria:

* People aged \> 65 years
* Sarcopenia diagnosis (Tyrovolas et al., 2015)
* Medically stable at least 2 months before the study

Exclusion Criteria:

* Cardiorespiratory, muscular, neurological, or neuromuscular disease that could interfere in the proper performance of assessment and/or training protocols.
* Endocrine and metabolic disorders that might have had an effect on muscle mass.
* Severe disorder of hydration status that could interfere in Bioelectrical Impedance Analysis (Rubbieri et al., 2014).
* A terminal disease diagnosis.
* Mini-Mental State Examination Index ≤ 20 score.

Primary outcomes:
measure: Change in Muscle mass
timeFrame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
measure: Change in Maximum Respiratory Pressures (MIP and MEP)
timeFrame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
measure: Change in Handgrip strength
timeFrame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
measure: Change in peripheral muscle strength
timeFrame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Secondary outcomes:
measure: Change in Maximal Voluntary Ventilation (MVV)
timeFrame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
measure: Change in Time performed to walk 10 m distance (10mWT).
timeFrame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Other outcomes:
measure: Falls and fractures
timeFrame: Intervention costs will be recorded from the time zero to 12-weeks.
measure: Intervention costs
timeFrame: Intervention costs will be recorded from the time zero to 12-weeks.
Locations:
city: Valencia
country: Spain
facility: Grupo Gero Residencias "La Saleta"
Study officials:
affiliation: University of Valencia
name: Maria A Cebrià i Iranzo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: María A Tortosa Chuliá, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: María J Ponce Darós, PT, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Mercè Balasch i Bernat, PT, PhD
role: STUDY_CHAIR
References:
citation: Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
citation: Cruz-Jentoft AJ, Triana FC, Gomez-Cabrera MC, Lopez-Soto A, Masanes F, Martin PM, Rexach JA, Hidalgo DR, Salva A, Vina J, Formiga F. [The emergent role of sarcopenia: Preliminary Report of the Observatory of Sarcopenia of the Spanish Society of Geriatrics and Gerontology]. Rev Esp Geriatr Gerontol. 2011 Mar-Apr;46(2):100-10. doi: 10.1016/j.regg.2010.11.004. Epub 2011 Jan 8. Spanish.
citation: Doherty TJ. Invited review: Aging and sarcopenia. J Appl Physiol (1985). 2003 Oct;95(4):1717-27. doi: 10.1152/japplphysiol.00347.2003.
citation: Tyrovolas S, Koyanagi A, Olaya B, Ayuso-Mateos JL, Miret M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM. The role of muscle mass and body fat on disability among older adults: A cross-national analysis. Exp Gerontol. 2015 Sep;69:27-35. doi: 10.1016/j.exger.2015.06.002. Epub 2015 Jun 3.