Preventive Physiotherapy Intervention in Elderly People With Sarcopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Sarcopenia Syndrome; Institutionalization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control group

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Respiratory training group

Participants will breathe against a load ≥ 50% of their baseline MIP, after which loads will increase according to the participant's tolerance across the remaining training period, using a Borg scale rating of 4 to 6 on perceived exertion as an indicator of adequate training intensity.

Intervention: Inspiratory Muscle training (12-weeks)

Group Type EXPERIMENTAL

Inspiratory Muscle Training (IMT).

Intervention Type OTHER

Supervised interval-based program consisting of seven cycles of 2-minutes work and 1-minute rest. This protocol is published as a practical guide for clinicians by Hill et al (2010).

The sessions will take place 3 times per week over a twelve-week period for a total of 36 sessions. All participants will be familiarized with the breathing exercises over a two-week familiarization period at the beginning of the protocol. The load will be adjusted at ≥ 50% of baseline MIP. Participants remain seated in groups of 8 to 10.

Peripheral training group

Participants will load ≥ 50% of their maximum muscle force (Kg), after which load will increase according to the participant's tolerance across the remaining training period, using a Borg scale rating of 4 to 6 on perceived exertion as an indicator of adequate training intensity.

Intervention: Peripheral muscle training (12-weeks)

Group Type EXPERIMENTAL

Peripheral muscle training

Intervention Type OTHER

The supervised training program consists of one cycle of 10 exercises, 12 repetitions each one. The main peripheral muscles to be trained will be those recommended by Cruz-Jentoft et al (2011): brachial biceps and triceps, pectorals, deltoid, hand flexors and extensors, spine extensor muscles, psoas-iliac, quadriceps femoris and sural triceps.

The sessions will take place 3 times per week over a twelve-week period for a total of 36 sessions. All participants were familiarized with the force exercises over a two-week familiarization period at the beginning of the protocol. The load will be adjusted at ≥ 50% of maximum muscle force. Participants remain seated in groups of 8 to 10.

Interventions

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Inspiratory Muscle Training (IMT).

Supervised interval-based program consisting of seven cycles of 2-minutes work and 1-minute rest. This protocol is published as a practical guide for clinicians by Hill et al (2010).

The sessions will take place 3 times per week over a twelve-week period for a total of 36 sessions. All participants will be familiarized with the breathing exercises over a two-week familiarization period at the beginning of the protocol. The load will be adjusted at ≥ 50% of baseline MIP. Participants remain seated in groups of 8 to 10.

Intervention Type OTHER

Peripheral muscle training

The supervised training program consists of one cycle of 10 exercises, 12 repetitions each one. The main peripheral muscles to be trained will be those recommended by Cruz-Jentoft et al (2011): brachial biceps and triceps, pectorals, deltoid, hand flexors and extensors, spine extensor muscles, psoas-iliac, quadriceps femoris and sural triceps.

The sessions will take place 3 times per week over a twelve-week period for a total of 36 sessions. All participants were familiarized with the force exercises over a two-week familiarization period at the beginning of the protocol. The load will be adjusted at ≥ 50% of maximum muscle force. Participants remain seated in groups of 8 to 10.

Intervention Type OTHER

Other Intervention Names

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Threshold IMT (Respironics Health Inc. Cedar Grove, NJ, USA)

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No