The Feasibility of a Dynamic Exercise Intervention. Psychosocial Effects and Process Evaluation of the Experimental Design.

NCT04932408 | Unknown

• 1 other identifier: UDerby
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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. 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 accessibility, acceptability and appropriateness of an elastic band exercise intervention with older adults by performing selected activities followed by researcher led interviews that will focus on the participants influences, perceptions and psycho-social factors related the intervention activities.

Conditions

Stability; Old Age; Debility; Balance; Distorted

Outcome Measures

Primary Outcomes (3)

• 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 (2)

• Mini Balance Evaluation Test (MINI-BESTest)

  through study completeion, an average of 1 year

• Short Falls efficacy scale

  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 (2)

Hip Region

EXPERIMENTAL

Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed around 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- Semi-structured Interview schedule

Other: Evaluation of the feasibility, psychosocial effects, influence and perception of exercise selection an experimental design of exercises performed at the hip and chest region.

Chest Region

EXPERIMENTAL

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- Semi-structured Interview schedule

Other: Evaluation of the feasibility, psychosocial effects, influence and perception of exercise selection an experimental design of exercises performed at the hip and chest region.

Interventions

Evaluation of the feasibility, psychosocial effects, influence and perception of exercise selection an experimental design of exercises performed at the hip and chest region. OTHER

A single exposure feasibility study 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. 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 feasibility of using Elastic Resistance Bands in Older Adults, Novel Elastic Resistance Band training Intervention in Older Adults, Feasibility study on a Novel Elastic Resistance Band training Intervention

Chest Region; Hip Region

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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)

Sponsors & Collaborators

• University of Derby: lead

Study Sites (1)

University of Derby

Derby, de22 11gb, United Kingdom

RECRUITING

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.

  PMID: 15304540 BACKGROUND

• 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.

  PMID: 11217890 BACKGROUND

• 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.

  PMID: 20703977 BACKGROUND

• 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.

  PMID: 18714245 BACKGROUND

• 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.

  PMID: 11322678 BACKGROUND

• 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.

  PMID: 28621015 BACKGROUND

• 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.

  PMID: 29535589 BACKGROUND

• 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.

  PMID: 26048054 BACKGROUND

• 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.

  PMID: 17540020 BACKGROUND

• 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.

  PMID: 23921445 BACKGROUND

Related Links

• Department of Health- Physical activity guidelines
• NHS Overview on Falls

MeSH Terms

Conditions

Frailty

Interventions

Aging

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Officials

• Andy Pringle, PhD

  University of Derby

  STUDY DIRECTOR

Central Study Contacts

Nichola M Davis, MSc

CONTACT

07792486602; n.davis@derby.ac.uk

Minas Mina, PhD

CONTACT

07774014822; M.Mina@derby.ac.uk

Study Design

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

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 21, 2021
• Study Start: August 6, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)