Effects and Costs of Preventive Physiotherapy Intervention in Institutionalized Elderly People With Sarcopenia: A Randomized Controlled Trial
Sponsor study identifier
Secondary identifiers
OTHER · University of Valencia Research Ethics Committee
interventional
91
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
April 16, 2014
Actual (reported)April 23, 2014
Actual (reported)March 2016
Actual (reported)June 2016
Actual (reported)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.
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
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.
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
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 Maximal Voluntary Ventilation (MVV)
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Change in Time performed to walk 10 m distance (10mWT).
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Falls and fractures
Intervention costs will be recorded from the time zero to 12-weeks.
Intervention costs
Intervention costs will be recorded from the time zero to 12-weeks.
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)
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.
Grupo Gero Residencias "La Saleta"
Valencia, 46015, Spain
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.
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.
Maria A Cebrià i Iranzo, PT, PhD
University of Valencia
María A Tortosa Chuliá, PhD
University of Valencia
María J Ponce Darós, PT, PhD
University of Valencia
Mercè Balasch i Bernat, PT, PhD
University of Valencia
91 participants (actual enrollment reported by the registry).
First Submitted
April 16, 2014
First Posted
April 23, 2014
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Protein Supplementation and Muscle Function in the Elderly
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
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.
The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Doherty TJ. Invited review: Aging and sarcopenia. J Appl Physiol (1985). 2003 Oct;95(4):1717-27. doi: 10.1152/japplphysiol.00347.2003.
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.
Primary Completion
March 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
November 15, 2018
Record last verified: 2017-07
Results are published in a J Aging Phys Act. 2018. 1;26(4):637-646.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: