NCT03297632

Brief Summary

Falls and fractures are serious and costly events for elderly individuals: they cause functional impairments, increase mortality and contribute to huge healthcare costs for the society. The number of falls, and following consequences, are expected to increase in society as the proportion of the elderly population will increase, therefore it is crucial to be able to detect and prevent falls and fractures in the population. The investigators have previously published results that objective measurements of postural balance can predict fall risk in 70-year-olds in Umeå and subsequently investigated whether balance can be improved through 4-week balance exercise program. However, preliminary results suggest that the frequency and duration of exercise should be longer than 3 times a week for 4 weeks to produce effects. Furthermore, there is also evidence indicating a link between muscle weakness and fall risk in elderly subjects, while research findings show that it is possible for older individuals to influence muscle strength and muscle mass with resistance exercise. Functional strength training can also positively influence the balance. In this context, the investigators aim to investigate whether a 10-week resistance exercise program may positively affect balance, muscle strength, muscle mass and physical function, with the aim of preventing future falls and fractures in the population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

September 18, 2017

Last Update Submit

October 25, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Postural Stability performance

    Postural stability measurement task from the Short Physical Performance Battery (SPPB), containing bipedal, semi-tandem and tandem stances. Measured in seconds, up to a maximal value of 10 seconds.

    Change in Postural Stability performance at 10 and 34 weeks

  • Change in Gait Speed

    Gait speed measurement task from the Short Physical Performance Battery (SPPB). Measured in the seconds it takes to walk 4 meters.

    Change in Gait Speed at 10 and 34 weeks

  • Change in Chair Stand performance

    Chair stand measurement task from the Short Physical Performance Battery (SPPB). Measures in the time it takes to stand up 5 times.

    Change in Chair stand performance at 10 and 34 weeks

Secondary Outcomes (7)

  • Change in Postural Sway

    Change in Baseline Postural Sway at 10 and 34 weeks

  • Change in Isometric Muscle Strength

    Change in Baseline Isometric Muscle Strength at 10 and 34 weeks

  • Change in Appendicular Muscle Mass

    Change in Baseline Appendicular Muscle Mass at 10 and 34 weeks

  • Change in TUG test performance

    Change in Baseline TUG test performance at 10 and 34 weeks

  • Change in Physical Activity

    Change in Baseline Physical Activity at 10 and 34 weeks

  • +2 more secondary outcomes

Study Arms (3)

Intervention Group

EXPERIMENTAL

Receives instructor-based functional resistance exercise. 45 minutes per session. 3 times per week, during 10 weeks in total.

Behavioral: Functional resistance exercise

Control group

NO INTERVENTION

Asked to normally active according to their current lifestyle

Home-based group

ACTIVE COMPARATOR

Receives home-based exercises with written instructions and digital video support. 45 minutes per session. 3 times per week, during 10 weeks in total.

Behavioral: Functional resistance exercise

Interventions

Functional resistance program designed for older individuals with low muscle mass and muscle strength. The goal is to implement exercises that are possible for the participants to also perform in their home environment, through the use of basic equipment.

Home-based groupIntervention Group

Eligibility Criteria

Age70 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Participation in the Healthy Ageing Initiative (HAI) study
  • Appendicular lean mass index in the lowest 20% measured with the iDXA in the HAI study, separate for men and women.

You may not qualify if:

  • Unable to be present during all 10 weeks of exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Livsmedicin (LIFE)

Umeå, Västerbotten County, 907 36, Sweden

Location

Related Publications (23)

  • Stel VS, Smit JH, Pluijm SM, Lips P. Consequences of falling in older men and women and risk factors for health service use and functional decline. Age Ageing. 2004 Jan;33(1):58-65. doi: 10.1093/ageing/afh028.

    PMID: 14695865BACKGROUND
  • Wolinsky FD, Fitzgerald JF, Stump TE. The effect of hip fracture on mortality, hospitalization, and functional status: a prospective study. Am J Public Health. 1997 Mar;87(3):398-403. doi: 10.2105/ajph.87.3.398.

    PMID: 9096540BACKGROUND
  • Rizzo JA, Friedkin R, Williams CS, Nabors J, Acampora D, Tinetti ME. Health care utilization and costs in a Medicare population by fall status. Med Care. 1998 Aug;36(8):1174-88. doi: 10.1097/00005650-199808000-00006.

    PMID: 9708590BACKGROUND
  • Masud T, Morris RO. Epidemiology of falls. Age Ageing. 2001 Nov;30 Suppl 4:3-7. doi: 10.1093/ageing/30.suppl_4.3. No abstract available.

    PMID: 11769786BACKGROUND
  • Robinovitch SN, Feldman F, Yang Y, Schonnop R, Leung PM, Sarraf T, Sims-Gould J, Loughin M. Video capture of the circumstances of falls in elderly people residing in long-term care: an observational study. Lancet. 2013 Jan 5;381(9860):47-54. doi: 10.1016/S0140-6736(12)61263-X. Epub 2012 Oct 17.

    PMID: 23083889BACKGROUND
  • Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. N Engl J Med. 1988 Dec 29;319(26):1701-7. doi: 10.1056/NEJM198812293192604.

    PMID: 3205267BACKGROUND
  • Maki BE, Holliday PJ, Topper AK. A prospective study of postural balance and risk of falling in an ambulatory and independent elderly population. J Gerontol. 1994 Mar;49(2):M72-84. doi: 10.1093/geronj/49.2.m72.

    PMID: 8126355BACKGROUND
  • Piirtola M, Era P. Force platform measurements as predictors of falls among older people - a review. Gerontology. 2006;52(1):1-16. doi: 10.1159/000089820.

    PMID: 16439819BACKGROUND
  • Lord SR, Sambrook PN, Gilbert C, Kelly PJ, Nguyen T, Webster IW, Eisman JA. Postural stability, falls and fractures in the elderly: results from the Dubbo Osteoporosis Epidemiology Study. Med J Aust. 1994 Jun 6;160(11):684-5, 688-91.

    PMID: 8202002BACKGROUND
  • Moe-Nilssen R, Nordin E, Lundin-Olsson L; Work Package 3 of European Community Research Network Prevention of Falls Network Europe. Criteria for evaluation of measurement properties of clinical balance measures for use in fall prevention studies. J Eval Clin Pract. 2008 Apr;14(2):236-40. doi: 10.1111/j.1365-2753.2007.00839.x.

    PMID: 18324932BACKGROUND
  • Howcroft J, Kofman J, Lemaire ED. Review of fall risk assessment in geriatric populations using inertial sensors. J Neuroeng Rehabil. 2013 Aug 8;10(1):91. doi: 10.1186/1743-0003-10-91.

    PMID: 23927446BACKGROUND
  • Visser JE, Carpenter MG, van der Kooij H, Bloem BR. The clinical utility of posturography. Clin Neurophysiol. 2008 Nov;119(11):2424-36. doi: 10.1016/j.clinph.2008.07.220. Epub 2008 Sep 12.

    PMID: 18789756BACKGROUND
  • Scaglioni-Solano P, Aragon-Vargas LF. Validity and reliability of the Nintendo Wii Balance Board to assess standing balance and sensory integration in highly functional older adults. Int J Rehabil Res. 2014 Jun;37(2):138-43. doi: 10.1097/MRR.0000000000000046.

    PMID: 24445863BACKGROUND
  • Kwok BC, Clark RA, Pua YH. Novel use of the Wii Balance Board to prospectively predict falls in community-dwelling older adults. Clin Biomech (Bristol). 2015 Jun;30(5):481-4. doi: 10.1016/j.clinbiomech.2015.03.006. Epub 2015 Mar 11.

    PMID: 25796535BACKGROUND
  • Johansson J, Nordstrom A, Gustafson Y, Westling G, Nordstrom P. Increased postural sway during quiet stance as a risk factor for prospective falls in community-dwelling elderly individuals. Age Ageing. 2017 Nov 1;46(6):964-970. doi: 10.1093/ageing/afx083.

    PMID: 28531243BACKGROUND
  • Cederholm T, Cruz-Jentoft AJ, Maggi S. Sarcopenia and fragility fractures. Eur J Phys Rehabil Med. 2013 Feb;49(1):111-7.

    PMID: 23575205BACKGROUND
  • Borde R, Hortobagyi T, Granacher U. Dose-Response Relationships of Resistance Training in Healthy Old Adults: A Systematic Review and Meta-Analysis. Sports Med. 2015 Dec;45(12):1693-720. doi: 10.1007/s40279-015-0385-9.

    PMID: 26420238BACKGROUND
  • Yu W, An C, Kang H. Effects of Resistance Exercise Using Thera-band on Balance of Elderly Adults: A Randomized Controlled Trial. J Phys Ther Sci. 2013 Nov;25(11):1471-3. doi: 10.1589/jpts.25.1471. Epub 2013 Dec 11.

    PMID: 24396213BACKGROUND
  • de Labra C, Guimaraes-Pinheiro C, Maseda A, Lorenzo T, Millan-Calenti JC. Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials. BMC Geriatr. 2015 Dec 2;15:154. doi: 10.1186/s12877-015-0155-4.

    PMID: 26626157BACKGROUND
  • Iolascon G, Di Pietro G, Gimigliano F, Mauro GL, Moretti A, Giamattei MT, Ortolani S, Tarantino U, Brandi ML. Physical exercise and sarcopenia in older people: position paper of the Italian Society of Orthopaedics and Medicine (OrtoMed). Clin Cases Miner Bone Metab. 2014 Sep;11(3):215-21.

    PMID: 25568656BACKGROUND
  • Veronese N, Bolzetta F, Toffanello ED, Zambon S, De Rui M, Perissinotto E, Coin A, Corti MC, Baggio G, Crepaldi G, Sergi G, Manzato E. Association between Short Physical Performance Battery and falls in older people: the Progetto Veneto Anziani Study. Rejuvenation Res. 2014 Jun;17(3):276-84. doi: 10.1089/rej.2013.1491. Epub 2014 Jun 11.

    PMID: 24387140BACKGROUND
  • LIFE Study Investigators; Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1157-65. doi: 10.1093/gerona/61.11.1157.

    PMID: 17167156BACKGROUND
  • Vikberg S, Sorlen N, Branden L, Johansson J, Nordstrom A, Hult A, Nordstrom P. Effects of Resistance Training on Functional Strength and Muscle Mass in 70-Year-Old Individuals With Pre-sarcopenia: A Randomized Controlled Trial. J Am Med Dir Assoc. 2019 Jan;20(1):28-34. doi: 10.1016/j.jamda.2018.09.011. Epub 2018 Nov 7.

MeSH Terms

Conditions

Muscle WeaknessSarcopenia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsMuscular AtrophyAtrophyPathological Conditions, Anatomical

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 29, 2017

Study Start

September 4, 2017

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

October 26, 2018

Record last verified: 2018-10

Locations