Preventive Physiotherapy Intervention in Elderly People With Sarcopenia

NCT02120586 | Completed

• 1 other identifier: H1382044172319
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Syndrome; Institutionalization

Keywords

Elderly; Institutionalization; Sarcopenia; Strength training; Muscle mass; Muscle strength; Physical performance

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

Secondary Outcomes (2)

• 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).

Other Outcomes (2)

• 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.

Study Arms (3)

Control group

NO INTERVENTION

Usual care

Respiratory training group

EXPERIMENTAL

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)

Other: Inspiratory Muscle Training (IMT).

Peripheral training group

EXPERIMENTAL

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)

Other: Peripheral muscle training

Interventions

Inspiratory Muscle Training (IMT). 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.

Also known as: Threshold IMT (Respironics Health Inc. Cedar Grove, NJ, USA)

Respiratory training group

Peripheral muscle training 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.

Peripheral training group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Grupo Gero Residencias "La Saleta"

Valencia, 46015, Spain

Location

Related Publications (4)

• 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.

  PMID: 20392703 BACKGROUND

• 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.

  PMID: 21216498 BACKGROUND

• Doherty TJ. Invited review: Aging and sarcopenia. J Appl Physiol (1985). 2003 Oct;95(4):1717-27. doi: 10.1152/japplphysiol.00347.2003.

  PMID: 12970377 BACKGROUND

• 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.

  PMID: 26048566 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Syndrome

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease; Pathologic Processes

Study Officials

• Maria A Cebrià i Iranzo, PT, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

• María A Tortosa Chuliá, PhD

  University of Valencia

  STUDY CHAIR

• María J Ponce Darós, PT, PhD

  University of Valencia

  STUDY CHAIR

• Mercè Balasch i Bernat, PT, PhD

  University of Valencia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 23, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 15, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2018 Oct
• Access Criteria: doi: 10.1123/japa.2017-0268

Locations

ES (1)