Improving Balance Through Balance Exercise

NCT03227666 | Completed

• 1 other identifier: VCC-LIFE-2
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Today most fracture prevention measures targets the bone and osteoporosis. However, only about 20% of individuals with fractures have osteoporosis and at least 90% of all fractures are caused by a fall. Therefore, the present project builds on previous findings from our group identifying postural sway as an important risk factor for falls and aims to intervene against this risk factor in a randomized controlled trial targeting subjects at the highest risk for falls.

Conditions

Balance; Distorted; Fall

Keywords

Postural sway; Progressive balance exercise; RCT; Functional balance

Outcome Measures

Primary Outcomes (1)

• Change in Postural Sway

  Total postural sway length, measured objectively during trials of eyes open and eyes closed, during 60 seconds each

  Change in Baseline Postural Sway at 4 weeks

Secondary Outcomes (5)

• Prospective Falls

  6,12 and 24 months after intervention

• Change in Time-up-and-go (TUG) Performance

  Change in Baseline TUG Performance at 4 weeks

• Change in Balance Self-efficacy

  Change in Baseline Balance Self-efficacy at 4 weeks

• Change in Fear of Falling (FOF)

  Change in Baseline FOF at 4 weeks

• Change in Muscle Strength

  Change in Baseline Muscle Strength at 4 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will perform three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks.

Behavioral: Exercise

Control group

NO INTERVENTION

The control group recieves a health consultation that highlights the importance of physical activity and balance exercise according to standard practice within the HAI project. They are asked to return after 4 weeks for follow up.

Interventions

Exercise BEHAVIORAL

The intervention group will perform three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in the HAI study, having postural sway \> 400 mm during Eyes Open trial or \> 920 mm during Eyes Closed trial

You may not qualify if:

• Walking aid

Sponsors & Collaborators

• Region Västerbotten: lead
• Swedish Research Council, Kamprad Family Foundation, Kempe Foundation: collaborator

Study Sites (1)

Livsmedicin (LIFE)

Umeå, Västerbotten County, 907 36, Sweden

Location

Related Publications (20)

• 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: 14695865 BACKGROUND

• 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: 9096540 BACKGROUND

• 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: 9708590 BACKGROUND

• 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: 11769786 BACKGROUND

• 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: 23083889 BACKGROUND

• 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: 3205267 BACKGROUND

• 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: 8126355 BACKGROUND

• 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: 16439819 BACKGROUND

• 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: 8202002 BACKGROUND

• 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: 18324932 BACKGROUND

• 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: 23927446 BACKGROUND

• 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: 18789756 BACKGROUND

• 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: 24445863 BACKGROUND

• 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: 25796535 BACKGROUND

• Johansson J, Nordstrom A, Nordstrom P. Objectively measured physical activity is associated with parameters of bone in 70-year-old men and women. Bone. 2015 Dec;81:72-79. doi: 10.1016/j.bone.2015.07.001. Epub 2015 Jul 4.

  PMID: 26151120 BACKGROUND

• Johansson J, Nordstrom A, Nordstrom P. Greater Fall Risk in Elderly Women Than in Men Is Associated With Increased Gait Variability During Multitasking. J Am Med Dir Assoc. 2016 Jun 1;17(6):535-40. doi: 10.1016/j.jamda.2016.02.009. Epub 2016 Mar 19.

  PMID: 27006336 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9. doi: 10.1093/ageing/afi196.

  PMID: 16267188 BACKGROUND

• Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.

  PMID: 2229948 BACKGROUND

• Sorlen N, Hult A, Nordstrom P, Nordstrom A, Johansson J. Short-term balance training and acute effects on postural sway in balance-deficient older adults: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2021 Mar 9;13(1):23. doi: 10.1186/s13102-021-00251-x.

  PMID: 33750421 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anna Nordström, PhD

  Västerbotten County Council, Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Intervention group recieving exercise and control group recieving no exercise

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 24, 2017
• Study Start: April 1, 2017
• Primary Completion: August 12, 2017
• Study Completion: August 30, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)