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

Primary Purpose

Stability, Old Age; Debility, Balance; Distorted

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Evaluation of the feasibility, psychosocial effects, influence and perception of exercise selection an experimental design of exercises performed at the hip and chest region.
Sponsored by
University of Derby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stability

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • University of DerbyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hip Region

Chest Region

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Mini Balance Evaluation Test (MINI-BESTest)
This assessment will require participants to perform a series of physical performance tasks. Following each task, the researcher will record the scores to sum a total score for the MINI BESTest. Scoring: The test has a maximum score of 28 points from 14 items that are each scored from 0-2. "0" = lowest level of function and "2" = highest level of function. If a subject must use an assistive device for an item, score that item one category lower. If a subject requires physical assistance to perform an item, score "0" for that item.
Short Falls efficacy scale
This questionnaire will require the participant to answer 7 questions on their own perceptions on concerns of falling during a series of activities. The scale for each questions is measured from a value of 1-4. 1 = not concerned at all about falling and a 4 =very concerned about falling for each item. A higher score on the FES-l will represent a greater concern for falls from a participant (lowest score 7 and highest score 28).

Full Information

First Posted
June 6, 2021
Last Updated
August 6, 2021
Sponsor
University of Derby
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1. Study Identification

Unique Protocol Identification Number
NCT04932408
Brief Title
The Feasibility of a Dynamic Exercise Intervention. Psychosocial Effects and Process Evaluation of the Experimental Design.
Official Title
Evaluation of the Feasibility, Psychosocial Effects, Influence and Perception of Exercise Selection and Experimental Design of Exercises Performed.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Derby

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Outline of study design The following study will be designed as a single exposure, qualitative (one-to-one interviews using a semi-structured interview guide) and quantitative (heart rate and rate of perceived exertion ratings) study. A convenience sample of adults/older adults will be recruited through PA networks in the Derbyshire community. Participants will take part in one experimental session: performing exercises with an elastic resistance band placed at the hip and chest region. The session order of band placement will be randomized for each participant to counter-balance the outcome which emerge from the study. Participant preparation Following a detailed briefing using a pre-prepared participant information sheet, a signed informed consent form and Instrumental Activities of Daily Living form, participants will be required to complete 2 supervised visits to the laboratory at the University of Derby. Participants will complete a general health screening questionnaire. Specific instructions will be provided for participants to abstain from alcohol and caffeine for a minimum of 12/24 hours respectively and avoidance of strenuous exercise for at least 72 hours prior to participation. Outline of study methods Participants will be required to attend the University Laboratory (Kblock) to take part in the study. Due to COVID-19 participants will be required to adhere to the latest government guidance and guidance from the University to consider this assessment to be safe (Risk assessments in place). Baseline assessments: Mini Balance Evaluation (MINI BESTest) Short Falls Efficacy Scale (Short FES-I) Following a briefing, participants will be required to perform a 10 minute supervised warm up and mobility session prior to exercise. Participants will be required to perform a selection of 8 pre-selected exercises whilst wearing the elastic band around the hip or chest region (randomized) with a 20 minute rest in between each condition). Participants will perform the exercises with the lowest resistance of 2-15lb aimed at low/moderate intensity. Heart rate (HR) on a heart rate strap and watch, rate of perceived exertion (RPE) (Borg scale) will be measured to assess exercise intensity. All sessions will be closely supervised by the lead researcher -a qualified postural stability instructor, (level 4 reps Postural Stability Instructor trained by Later Life Training), that will provide prompts on form of the exercises. Elastic band placement Hip region: Each participant will be required to perform the series of exercises whilst attached to an elastic resistance band. The elastic band will be attached from ground level which will be attached to the participant over the hip region with padding. Chest region Each participant will be required to perform a series of exercises whilst attached to an elastic resistance band. The elastic band will be attached from ground level and to the participant over the chest region (under arms) , using Velcro on a chest harness/training vest. Immediately following the single-session exercise intervention, participants will be required to attend 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stability, Old Age; Debility, Balance; Distorted

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hip Region
Arm Type
Experimental
Arm Description
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
Arm Title
Chest Region
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
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 Intervention Name(s)
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
Intervention Description
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.
Primary Outcome Measure Information:
Title
Semi structured Interview
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Heart rate
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Rate of perceived exertion (RPE)
Description
RPE measures will be taken during each exercise. Scale 0-10. 0= no exertion and 10 being the highest exertion- exhaustion.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Mini Balance Evaluation Test (MINI-BESTest)
Description
This assessment will require participants to perform a series of physical performance tasks. Following each task, the researcher will record the scores to sum a total score for the MINI BESTest. Scoring: The test has a maximum score of 28 points from 14 items that are each scored from 0-2. "0" = lowest level of function and "2" = highest level of function. If a subject must use an assistive device for an item, score that item one category lower. If a subject requires physical assistance to perform an item, score "0" for that item.
Time Frame
through study completeion, an average of 1 year
Title
Short Falls efficacy scale
Description
This questionnaire will require the participant to answer 7 questions on their own perceptions on concerns of falling during a series of activities. The scale for each questions is measured from a value of 1-4. 1 = not concerned at all about falling and a 4 =very concerned about falling for each item. A higher score on the FES-l will represent a greater concern for falls from a participant (lowest score 7 and highest score 28).
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Instrumental Activities of Daily Living form (IADL)
Description
To identify how a person is functioning at the present time to determine any differences in participation recruitment. The IADL has 8 categories which the participant is required to select one out of four options that have a score assigned to their level of functioning (either 1 or 0). Scoring Interpretation: In some activities and categories, only the highest level of function receives a 1; in others, two or more levels have scores of 1 because each describes competence that represents some minimal level of function. These screens are useful for indicating specifically how a person is performing at the present time. Therefore a higher score on the IADL would represent a higher functioning level. Highest score= 8 (high functioning), lowest score =0 (low functioning).
Time Frame
through study completion, an average of 1 year
Title
International physical activity questionnaire (IPARQ)
Description
IPAQ assesses physical activity undertaken across a set of domains. The following values are used for the analysis: Walking = 3.3 METs, Moderate PA = 4.0 METs and Vigorous PA = 8.0 METs. Low= Individuals who not meet criteria for Categories 2 or 3 are considered to have a 'low' physical activity level. Moderate= a) 3 or more days of vigorous-intensity activity of at least 20 minutes per day b) 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day c) 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum Total physical activity of at least 600 MET-minutes/week. High= a) vigorous-intensity activity on at least 3 days achieving a minimum Total physical activity of at least 1500 MET-minutes/week b) 7 or more days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum Total physical activity of at least 3000 MET-minutes/week.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nichola M Davis, MSc
Phone
07792486602
Email
n.davis@derby.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Minas Mina, PhD
Phone
07774014822
Email
M.Mina@derby.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy Pringle, PhD
Organizational Affiliation
University of Derby
Official's Role
Study Director
Facility Information:
Facility Name
University of Derby
City
Derby
ZIP/Postal Code
de22 11gb
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minas Mina, PhD
Phone
07774014822
Email
M.mina@derby.ac.uk
First Name & Middle Initial & Last Name & Degree
Andy Pringle, PhD
Phone
07931714203
Email
A.pringle@derby.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15304540
Citation
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.
Results Reference
background
PubMed Identifier
11217890
Citation
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.
Results Reference
background
PubMed Identifier
20703977
Citation
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.
Results Reference
background
PubMed Identifier
18714245
Citation
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.
Results Reference
background
PubMed Identifier
11322678
Citation
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.
Results Reference
background
PubMed Identifier
28621015
Citation
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.
Results Reference
background
PubMed Identifier
29535589
Citation
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.
Results Reference
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PubMed Identifier
26048054
Citation
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.
Results Reference
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PubMed Identifier
17540020
Citation
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.
Results Reference
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PubMed Identifier
23921445
Citation
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.
Results Reference
background
Links:
URL
https://www.gov.uk/government/publications/physical-activity-guidelines-uk-chief-medical-officers-report
Description
Department of Health- Physical activity guidelines
URL
https://www.nhs.uk/conditions/Falls/
Description
NHS Overview on Falls
URL
https://www.laterlifetraining.co.uk/wp-content/uploads/2017/07/LLT-Guidance_Evidenced-Based-Falls-Prevention-Programmes_FaME_Otago_commissioning_240717.pdf
Description
Implementation Guidance for Commissioners, Public Health Officers and Leisure Service Managers

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

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