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Preventive Physiotherapy Intervention in Elderly People With Sarcopenia

Primary Purpose

Sarcopenia, Syndrome; Institutionalization

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inspiratory Muscle Training (IMT).
Peripheral muscle training
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Elderly, Institutionalization, Sarcopenia, Strength training, Muscle mass, Muscle strength, Physical performance

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grupo Gero Residencias "La Saleta"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Respiratory training group

Peripheral training group

Arm Description

Usual care

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)

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)

Outcomes

Primary Outcome Measures

Change in Muscle mass
Bioimpedance analysis (BIA) estimates the volume of fat and lean body mass. The test itself is inexpensive, easy to use, readily reproducible and appropriate for both ambulatory and bedridden patients. Reference: J Aging Phys Act 2015;23(4):597-606. Korean J Intern Med 2016;31:643-650.
Change in Maximum Respiratory Pressures (MIP and MEP)
MIP and MEP are probably the most frequently reported non-invasive estimates of respiratory muscle strength. Ever since Black and Hyatt (1969) reported this technique it has been widely used in patients, healthy control subjects across all ages, and athletes. Pressure is recorded at the mouth during a quasi-static short (few seconds) maximal breathing. Reference: Am J Respir Crit Care Med. 2002;166:531-535.
Change in Handgrip strength
Isometric hand grip strength is strongly related with lower extremity muscle power, knee extension torque and calf cross-sectional muscle area. In practice, there is also a linear relationship between baseline handgrip strength and incident disability for activities of daily living. Reference: Age and Aging. 2010;39:412-423.
Change in peripheral muscle strength
Maximal isometric muscle strength (Kg) was assessed for knee extension (Quadriceps femoris) and elbow flexion (Biceps brachii). Reference: J Am Geriatr Soc 2002; 50: 461-7.

Secondary Outcome Measures

Change in Maximal Voluntary Ventilation (MVV)
This ventilatory test is a non-invasive technique and is a measure of both inspiratory and expiratory muscle endurance. The MVV is the largest volume that can be breathed in and out of the lungs during a 12 -15 second interval with maximal voluntary effort. Reference: Am J Respir Crit Care Med. 2002;166:562-564.
Change in Time performed to walk 10 m distance (10mWT).
The 10-Meter Walk Test (10mWT) is a measure of gait speed (measurement of physical performance). The walking course consist of 14 m in a hallway: a 2 m warm-up, 10 m use for the speed measurement, and 2 m for slowing down to stop. Participants can use the assistive device (eg, cane, walker) or orthotic device (eg, ankle-foot orthosis) that they use "most often" (if any) at each time point. Reference: Phys Ther. 2010;90(2):196-208.

Full Information

First Posted
April 16, 2014
Last Updated
November 13, 2018
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT02120586
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Syndrome; Institutionalization
Keywords
Elderly, Institutionalization, Sarcopenia, Strength training, Muscle mass, Muscle strength, Physical performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Respiratory training group
Arm Type
Experimental
Arm Description
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)
Arm Title
Peripheral training group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training (IMT).
Other Intervention Name(s)
Threshold IMT (Respironics Health Inc. Cedar Grove, NJ, USA)
Intervention Description
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
Intervention Name(s)
Peripheral muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Muscle mass
Description
Bioimpedance analysis (BIA) estimates the volume of fat and lean body mass. The test itself is inexpensive, easy to use, readily reproducible and appropriate for both ambulatory and bedridden patients. Reference: J Aging Phys Act 2015;23(4):597-606. Korean J Intern Med 2016;31:643-650.
Time Frame
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Title
Change in Maximum Respiratory Pressures (MIP and MEP)
Description
MIP and MEP are probably the most frequently reported non-invasive estimates of respiratory muscle strength. Ever since Black and Hyatt (1969) reported this technique it has been widely used in patients, healthy control subjects across all ages, and athletes. Pressure is recorded at the mouth during a quasi-static short (few seconds) maximal breathing. Reference: Am J Respir Crit Care Med. 2002;166:531-535.
Time Frame
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Title
Change in Handgrip strength
Description
Isometric hand grip strength is strongly related with lower extremity muscle power, knee extension torque and calf cross-sectional muscle area. In practice, there is also a linear relationship between baseline handgrip strength and incident disability for activities of daily living. Reference: Age and Aging. 2010;39:412-423.
Time Frame
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Title
Change in peripheral muscle strength
Description
Maximal isometric muscle strength (Kg) was assessed for knee extension (Quadriceps femoris) and elbow flexion (Biceps brachii). Reference: J Am Geriatr Soc 2002; 50: 461-7.
Time Frame
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Secondary Outcome Measure Information:
Title
Change in Maximal Voluntary Ventilation (MVV)
Description
This ventilatory test is a non-invasive technique and is a measure of both inspiratory and expiratory muscle endurance. The MVV is the largest volume that can be breathed in and out of the lungs during a 12 -15 second interval with maximal voluntary effort. Reference: Am J Respir Crit Care Med. 2002;166:562-564.
Time Frame
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Title
Change in Time performed to walk 10 m distance (10mWT).
Description
The 10-Meter Walk Test (10mWT) is a measure of gait speed (measurement of physical performance). The walking course consist of 14 m in a hallway: a 2 m warm-up, 10 m use for the speed measurement, and 2 m for slowing down to stop. Participants can use the assistive device (eg, cane, walker) or orthotic device (eg, ankle-foot orthosis) that they use "most often" (if any) at each time point. Reference: Phys Ther. 2010;90(2):196-208.
Time Frame
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Other Pre-specified Outcome Measures:
Title
Falls and fractures
Description
Number of falls and resulting fractures will be checked from the medical history of participants.
Time Frame
Intervention costs will be recorded from the time zero to 12-weeks.
Title
Intervention costs
Description
Intervention costs related to staff (supervision of training programs), consumables (Threshold IMT and weights-ballasts) and capital for intervention will be calculate in 2014 €. Reference: Rev Esp Geriatr Gerontol. 2014;49:203-209.
Time Frame
Intervention costs will be recorded from the time zero to 12-weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria A Cebrià i Iranzo, PT, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
María A Tortosa Chuliá, PhD
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
María J Ponce Darós, PT, PhD
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mercè Balasch i Bernat, PT, PhD
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
Facility Information:
Facility Name
Grupo Gero Residencias "La Saleta"
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Results are published in a J Aging Phys Act. 2018. 1;26(4):637-646.
IPD Sharing Time Frame
2018 Oct
IPD Sharing Access Criteria
doi: 10.1123/japa.2017-0268
IPD Sharing URL
https://www.ncbi.nlm.nih.gov/pubmed/29431561
Citations:
PubMed Identifier
20392703
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.
Results Reference
background
PubMed Identifier
21216498
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.
Results Reference
background
PubMed Identifier
12970377
Citation
Doherty TJ. Invited review: Aging and sarcopenia. J Appl Physiol (1985). 2003 Oct;95(4):1717-27. doi: 10.1152/japplphysiol.00347.2003.
Results Reference
background
PubMed Identifier
26048566
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.
Results Reference
background

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Preventive Physiotherapy Intervention in Elderly People With Sarcopenia

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