NCT05224362

Brief Summary

Current balance and stability interventions have been shown to improve balance through targeting balance impairments and retraining effects. However, there are key facilitators and barriers 'that older adults may face to participate in such interventions'. Additionally, physical activity interventions fail to integrate older adults into the co-design and co-production of PA interventions. The study will aim to identify the impact and practicalities of an exercise intervention in older adults by performing pre selected exercises with an elastic resistance band attached at the hip and chest region to challenge balance. Static posturography will assess the impacts of the exercise intervention on balance and stability. Researcher led interviews will focus on the participants perceptions of the activities and decision making of exercise selection by selecting components that they are confident to perform which is a key element to creating a practical and enjoyable exercise programme for the older population. This will co-create an intervention that is accessible, acceptable, and appropriate for older adults. The study will establish the physical impact and practicalities of a novel elastic band resistance exercise intervention in older adults by performing force plate posturography and researcher led interviews that will focus on the participants perceptions of the activities and intensity levels to co-create an intervention that is accessible, acceptable, and appropriate for older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 6, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

January 24, 2022

Last Update Submit

December 7, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Bertec Force plate posturography

    Centre of pressure displacement and velocity parameters will be measured using a Bertec force plate and Pro-Vec software. Measurements include the position traces of anterior-posterior and mediolateral centre of pressure to provide feedback of postural stability. In particular, the mean displacement, root-mean-squared distance from mean, root-mean-square-velocity and the mean velocity of centre of pressure. Participants will stand upright and relaxed in the centre of a portable Bertec force plate with hands on hips and feet touching each other. Data will be collected under 4 different conditions: normal standing with eyes open, normal standing with eyes closed, a tandem stance with eyes open and a tandem stance with eyes closed. This will enable the proprioception and vestibular system to be assessed. Postural sway will be measured in the anteroposterior and mediolateral directions.

    through study completion, an average of 1 year

  • Semi structured Interview

    A one-on-one, face to face semi-structured interview with the researcher to identify the impact and practicalities of the exercise intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. A semi-structured interview schedule developed by the lead researcher will investigate the acceptability, accessibility, appropriateness and usability of the protocol. Participants will be asked a series of open and closed questions and likert scales to provide perceptions of the exercise selection such as likes/ dislikes, safety, confidence, difficulty, enjoyment and band placement. This will help to build insights into the participant preferences which is an important element of the intervention design.

    through study completion, an average of 1 year

  • Heart rate

    Heart rate measures will be taken during each exercise. Higher values = higher exertion of each exercise performed. 50 beats per min - 120 = low, 120- 150 beats per min = moderate and 150 beats per min = high.

    through study completion, an average of 1 year

  • Rate of perceived exertion (RPE)

    RPE measures will be taken during each exercise. Scale 0-10. 0= no exertion and 10 being the highest exertion exhaustion.

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • Mini Balance Evaluation Test (MINI-BESTest)

    through study completeion, an average of 1 year

  • Short Falls efficacy scale (FES 1)

    through study completion, an average of 1 year

  • Balance Confidence Questionnaire (CONFbal)

    through study completion, an average of 1 year

Other Outcomes (2)

  • Instrumental Activities of Daily Living form (IADL)

    through study completion, an average of 1 year

  • International physical activity questionnaire (IPARQ)

    through study completion, an average of 1 year

Study Arms (3)

Hip Region

EXPERIMENTAL

Pre intervention: Force plate Posturography Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed the hip region. Warm up: 5-10 mins Exercises: Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold. Cool down. Post intervention- Force plate Posturography and a Semi-structured Interview schedule

Device: A repeated measures acute study using using elastic resistance bands in older adults to challenge stability.

Chest Region

EXPERIMENTAL

Pre intervention: Force plate Posturography Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed the chest region (using velcro on a chest harness/training vest). Warm up: 5-10 mins Exercises: Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold. Cool down. Post intervention- Force plate Posturography and a Semi-structured Interview schedule

Device: A repeated measures acute study using using elastic resistance bands in older adults to challenge stability.

No elastic band

PLACEBO COMPARATOR

Pre intervention: Force plate Posturography Pre selected exercises (8) will be performed by the participant. Warm up: 5-10 mins Exercises: Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold. Cool down. Post intervention- Force plate Posturography and a Semi-structured Interview schedule

Device: A repeated measures acute study using using elastic resistance bands in older adults to challenge stability.

Interventions

A repeated measures acute study using using elastic resistance bands in older adults to challenge stability. Exercises with an elastic resistance band anchored from the ground and placed at the hip and chest region will be trialled. Bertec force plate analysis will be performed to assess the acute effects on balance and stability. A semi- structured interview will identify the impact and practicalities of the intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. Questions with verbal cues to provide perceptions of the exercise selection such as likes/ dislikes, safety, confidence, difficulty, enjoyment and band placement will be asked to determine the acceptability, accessibility, appropriateness and usability of the protocol and build insights into the participant preferences.

Also known as: Elastic Resistance Band Training, Balance training in Older Adults, Stability Training using Resistance bands in Older Adults, The acute effects of using Elastic Resistance Bands in Older Adults, Novel Elastic Resistance Band training Intervention in Older Adults, Bertec posturography, Resistance bands
Chest RegionHip RegionNo elastic band

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be male and females over 50 years old. Although ageing is an individual and qualitative perspective rather than solely a chronological perspective, adults are transitioning to older adulthood in their 5th decade of life. Older adults may benefit from preparing at an earlier stage of ageing from the age of 50 years compared to beginning at the age of 65 years where falls are a high risk factor. PA guidelines recommend that adults will benefit from preparing physical attributes such as strength and balance at an earlier stage of the ageing process, therefore, this age group of 50 years and over has been selected as the most appropriate.
  • Moderately Physically active (this will be determined by the International Physical Activity Questionnaire (IPAQ) prior to participation of the study. A score of at least 600 MET-min/week (moderate physical activity level) will be required to take part in the study.
  • Ability to walk without a walking aid
  • Ability to provide consent. This will be determined by using the Mini Mental State Examination (MMSE) a score of under 23. The MMSE will assess cognitive function using scoring to ensure that participants are not cognitively impaired

You may not qualify if:

  • Individuals that are under the age of 50 years old
  • Individual that have serious, unstable cardiovascular conditions such as recent acute myocardial infarction; congestive heart failure; uncontrolled hypertension; serious musculoskeletal or neurologic conditions (including Parkinson's disease, Huntington's disease, acute stroke, paresis of the lower limbs and uncontrolled diabetes mellitus.
  • Individuals with acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
  • Individuals that are not physically active (METs score under 600 MET-min/ week). have severe cognitive impairment (inability to follow simple training instructions; and acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
  • Individuals that are unable to provide consent. This will be determined by using the Mini-Mental State Examination (MMSE).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Derby

Derby, de22 11gb, United Kingdom

Location

University Of Derby

Derby, DE22 1GB, United Kingdom

Location

Related Publications (10)

  • Barry BK, Carson RG. The consequences of resistance training for movement control in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):730-54. doi: 10.1093/gerona/59.7.m730.

  • Carroll TJ, Barry B, Riek S, Carson RG. Resistance training enhances the stability of sensorimotor coordination. Proc Biol Sci. 2001 Feb 7;268(1464):221-7. doi: 10.1098/rspb.2000.1356.

  • Colado JC, Garcia-Masso X, Pellicer M, Alakhdar Y, Benavent J, Cabeza-Ruiz R. A comparison of elastic tubing and isotonic resistance exercises. Int J Sports Med. 2010 Nov;31(11):810-7. doi: 10.1055/s-0030-1262808. Epub 2010 Aug 11.

  • Colado JC, Triplett NT. Effects of a short-term resistance program using elastic bands versus weight machines for sedentary middle-aged women. J Strength Cond Res. 2008 Sep;22(5):1441-8. doi: 10.1519/JSC.0b013e31817ae67a.

  • Gardner MM, Buchner DM, Robertson MC, Campbell AJ. Practical implementation of an exercise-based falls prevention programme. Age Ageing. 2001 Jan;30(1):77-83. doi: 10.1093/ageing/30.1.77.

  • Gerards MHG, McCrum C, Mansfield A, Meijer K. Perturbation-based balance training for falls reduction among older adults: Current evidence and implications for clinical practice. Geriatr Gerontol Int. 2017 Dec;17(12):2294-2303. doi: 10.1111/ggi.13082. Epub 2017 Jun 16.

  • Lima FF, Camillo CA, Gobbo LA, Trevisan IB, Nascimento WBBM, Silva BSA, Lima MCS, Ramos D, Ramos EMC. Resistance Training using Low Cost Elastic Tubing is Equally Effective to Conventional Weight Machines in Middle-Aged to Older Healthy Adults: A Quasi-Randomized Controlled Clinical Trial. J Sports Sci Med. 2018 Mar 1;17(1):153-160. eCollection 2018 Mar.

  • Mansfield A, Aqui A, Centen A, Danells CJ, DePaul VG, Knorr S, Schinkel-Ivy A, Brooks D, Inness EL, McIlroy WE, Mochizuki G. Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial. BMC Neurol. 2015 Jun 6;15:87. doi: 10.1186/s12883-015-0347-8.

  • Mansfield A, Peters AL, Liu BA, Maki BE. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial. BMC Geriatr. 2007 May 31;7:12. doi: 10.1186/1471-2318-7-12.

  • Youdas JW, Adams KE, Bertucci JE, Brooks KJ, Nelson MM, Hollman JH. Muscle activation levels of the gluteus maximus and medius during standing hip-joint strengthening exercises using elastic-tubing resistance. J Sport Rehabil. 2014 Feb;23(1):1-11. doi: 10.1123/jsr.2012-0082. Epub 2013 Aug 6.

Related Links

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andy Pringle

    University of Derby

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator: Miss Nichola Michelle Davis (PhD Student)

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 4, 2022

Study Start

April 6, 2022

Primary Completion

July 1, 2023

Study Completion

July 27, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations