Clinical trial NCT04932408: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stability
Old Age; Debility
Balance; Distorted
Lead sponsor: University of Derby
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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. 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.

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: 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
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
Study officials:
affiliation: University of Derby
name: Andy Pringle, PhD
role: STUDY_DIRECTOR
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