Clinical trial NCT05224362: Acute Effects of Elastic Band Resistance on Postural Stability and Physical Function in Older Adults
Official title: Acute Effects of Elastic Band Resistance Applied to the Hip and Chest Region on Postural Stability and Physical Function Before, Immediately and up to 30 Min After Exercise in Physically Active Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stability
Posturography
Balance
Old Age; Debility
Lead sponsor: University of Derby
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Detailed description: Outline of study designThe following study will be a repeated measures design. A convenience sample of adults/older adults will be recruited through PA networks in the Derbyshire community. Participants will not be recruited through HSN facilities or via any NHS platform. Participants will be required to attend three separate sessions with at least 48-72hours in between each session. Each session will be randomized in order to mitigate any bias and allow comparability of the 3 conditions. Experimental session one: Participants will be required to perform pre-selected exercises with an elastic resistance band placed at the hip region. Experimental session two: Participants will be required to perform pre-selected exercises with an elastic resistance band placed at the chest region. Experimental session three (control group): Participants will be required to perform pre-selected exercises without an elastic resistance band. The exercise intensity is measured throughout by RPE before, during and after each exercise.

intensity. Participants will be asked to simply perform the exercises not at any specific intensity. Force plate posturography measurements will be recorded before and immediately after and 30 minutes after the exercise intervention. The other quantitative measures (heart rate, rate of perceived exertion) will be recorded throughout the intervention and one-to-one interviews using a semi structured interview guide will be performed at the end of each session. The session order will be randomized for each participant to counterbalance the outcome which emerge from the study.

Participant preparation will include a detailed invitation to attend and briefing using a pre-prepared participant information sheet. Participants will be required to complete and return an International physical activity questionnaire, Falls efficacy scale, Confidence in maintaining balance and Instrumental Activities of Daily Living form.

Upon arrival of each session participants will be required to read and sign an informed consent form, a general health screen questionnaire and mini mental state examination. Participants will be required to complete all 3 sessions which will be supervised in the Kirtley building laboratory at the University of Derby (3 x experimental trial). 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.

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).

Primary outcomes:
measure: Bertec Force plate posturography
timeFrame: through study completion, an average of 1 year
measure: Semi structured Interview
timeFrame: through study completion, an average of 1 year
measure: Heart rate
timeFrame: through study completion, an average of 1 year
measure: Rate of perceived exertion (RPE)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Mini Balance Evaluation Test (MINI-BESTest)
timeFrame: through study completeion, an average of 1 year
measure: Short Falls efficacy scale (FES 1)
timeFrame: through study completion, an average of 1 year
measure: Balance Confidence Questionnaire (CONFbal)
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Instrumental Activities of Daily Living form (IADL)
timeFrame: through study completion, an average of 1 year
measure: International physical activity questionnaire (IPARQ)
timeFrame: through study completion, an average of 1 year
Locations:
city: Derby
country: United Kingdom
facility: University of Derby
city: Derby
country: United Kingdom
facility: University Of Derby
Study officials:
affiliation: University of Derby
name: Andy Pringle
role: STUDY_DIRECTOR
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