Older AdultsNCT05758727
Homebased Strength and Tai-chi Exercise Snacking for Improving Physical Function in Older Adults
A study testing Exercise intervention in people with Older Adults, run by University of Bath at 1 site in United Kingdom.
Trial summary
Engaging in muscle strength and balance (S\&B) exercises and has numerous health benefits for older adults, promoting greater mobility, reducing risk of falling, and overall improved health and wellbeing. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- People aged 65 or greater and are able to perform daily physical activity independently.
- Not regularly engaging in recreational sports or structured exercise (once a week or more).
- Citizen of UK or Taiwan.
- Individuals who are able to do the 5 reps sit-to-stand in less than 60s and the feet side-by-side stand for at least 10s, following the initial safety screening.
Who cannot join
- Individuals with current ongoing medication or treatment for injuries or illness that would impact on any of the study outcomes.
- Individuals with a current musculoskeletal injury that would preclude participation in exercise ascertained through preliminary screening.
- Individuals with contraindications to exercise including chest pain, dizziness, or loss of consciousness, or who have been instructed by their doctor to only do physical activity recommended by them.
- Individuals who have been diagnosed with dementia.
- Individuals who are unable to consent for themselves or complete the familiarisation / baseline screening by themselves.
- Individuals who score more than 8 on the Short Physical Performance Battery, score more than 6 between strength and balance sections, or score zero on any component of the test.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, Bath And North East Somerset
About this study
Official title: The Efficacy of Home-based Strength and Tai-chi Exercise Snacking for Improving Physical Function in Taiwanese and British Older Adults: a Randomised Control Trial.
Engaging in muscle strength and balance (S\&B) exercises and has numerous health benefits for older adults, promoting greater mobility, reducing risk of falling, and overall improved health and wellbeing. Given the rising age of global populations, reducing the burden associated with lost physical function is essential to minimise health and social care costs. Unfortunately, very few older adults engage in sufficient S\&B exercise to reap these benefits, with a lack of time, self-efficacy and access to leisure facilities cited as the key barriers. Finding innovative ways promote an acceptable and engaging format of S\&B exercise is consequently a public health priority.
One novel way that aims to address typical barriers to participation in older adults is through the promotion of exercise 'snacks', as opposed to a more traditional, lengthy structured exercise session at a leisure centre. Exercise snacking describes short bursts of exercise that are designed to be undertaken over a short period in the home environment and without the need for any specialised exercise clothing or equipment. In the initial laboratory and cross-sectional and pilot intervention research, the investigators have been testing two formats of 5-minute, twice-daily, strength exercise- and tai-chi-snacking, which has been shown to be acceptable and feasible to implement in older adults. This protocol presents initial efficacy for evoking improved physical function in people aged 65 years or more. The investigators' remote study demonstrated that remote assessment and delivery of 4-week exercise and tai-chi snacking interventions were acceptable and feasible. However, qualitative feedback indicated that exercise programmes may be more acceptable and interesting with simpler tai-chi movements and exercise snacking programme with upper body movements. Nevertheless, the investigators only recruited healthy older adults, doing short-term interventions in previous studies. This study aims to test the effectiveness of progressive S\&B interventions over a sustained period in pre-frail older adults.
Read the detailed description
This study will take place over approximately 3 months and involve 5 assessments remotely. A subset of 60 participants will be assessed in person to validate the remote assessment and undergo more in-depth assessments.
Assessment 1: Familiarisation Participants will be directed to a web page with the participant information sheet and a consent tick box. Participants will then complete an online screening questionnaire that will assess eligibility. After this, participants will undertake a familiarisation session either online (all participants) or in person (lab participants only) to become accustomed to the physical function tests and undergo an exercise safety assessment.
Assessment 2: Baseline assessment. After familiarisation, eligible participants will then complete an online baseline questionnaire assessing demographic details, physical activity levels and psychological outcomes. A functional assessment will be arranged over video calling software, and in the laboratory for the lab participants. Functional outcomes will be completed at this visit. Following the baseline assessment participants will be randomised to either the intervention group, or the waitlist control group.
Assessment 3 and 4: Mid intervention. Participants in the intervention group will be given an exercise teaching video and written instructions on how to safely perform the exercise at home by email. The intervention will take place over 12 weeks and consists of three progressive phases that will be self-selected by participants. The participants will be asked to do the exercises and progress to the next level if they pass the progress criteria which will be clearly explained in the exercise guides and instructional videos. The participants will also be asked to record self-reported exercise logs and RPE for each session they complete. Participants will undergo follow-up assessments at weeks 4 and 8 through video calls and in person (if in the lab study).
Assessment 5: Follow-up assessment. After 12 weeks, participants will complete another online survey containing all psychosocial variables and an evaluation of the usefulness and acceptability of their assigned exercise activities. Participants will also undergo follow-up physical performance tests through video calls and in person (if in the lab study) and a subset will undergo a qualitative evaluation to provide further feedback on the intervention.
- Conditions
- Older Adults
- Being tested
- Exercise intervention
- Keywords
- Exercise snacking, Tai-chi snacking, Older adults, Homebased exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionOther
The exercise programme is progressive and has three levels. Each bout of exercise and Tai-chi snacking consists of 5 exercises. Each exercise is performed for one minute with one minute rest in between. For exercise snacking movements (including leg exercise, shoulder exercise, single leg exercise, arm exercise, and ankle exercise), participants are encouraged to complete as many repetitions as possible of that exercise in that minute. For Tai-chi snacking movements (including single leg squat, trunk rotation, single leg stand, hip and knee exercise, and ankle mobility exercise), participants are encouraged to complete repetitions of each exercise at a self-selected pace that is comfortable for them to maintain for the full minute, with the aim being to complete the movements as accurately and smoothly as possible (based on correct posture and proper alignment).
| Study group | Role | What they receive |
|---|---|---|
| Home-based exercise group | Experimental | This group will be asked to practise the 'exercise snacking and Tai-chi snacking' exercises once each and record the exercise bouts in a log book. Receives: Other: Exercise intervention |
| Control group | No intervention | Usual care control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Short Physical Performance Battery (SPPB) between every 4 weeks
Participants will be asked to do the SPPB test which includes balance test, gait speed test, and chair stand test.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Secondary outcomes (18)
1RM of leg press
Participants will be asked to perform leg press on Keiser leg press machine.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Balance function
Single-leg stand
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Strength function
60 second sit-to-stand test
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Agility function
Timed-up-and-go
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Flexibility
Chair sit and reach test
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Quality of life and wellbeing: Life Satisfaction Scale
A 5-item scale designed to measure global cognitive judgments of one's life satisfaction which uses a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree. Individuals score 31-35 are classified as 'Extremely Satisfied', 26-30 as 'Satisfied', 21-25 as 'Slightly satisfied', 20 as 'Neutral', 15-19 as 'Slightly dissatisfied', 10-14 as 'Dissatisfied', and 5-9 as 'Extremely Dissatisfied'.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Physical activity level: the instrumental activities of daily living (IADL)
An 8-topic instrument to determine older adults' capability of living independently. Each topic is given a score of 0 or 1. A person is judged adequate to live independently if scored 1 and is judged to need assistant if scored 0.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Physical activity level: the International Physical Activity Questionnaire for elderly (IPAQ-E) (short form)
The short version of the IPAQ-E assesses physical activity in older adults using different domains including sedentary activities, walking (light-intensity activities), moderate-intensity activities and vigorous intensity activities. Participants are asked to provide the time and frequency they spend doing different-intensity activities in the last 7 days by the day of questionnaire completion. IPAQ data are calculated and presented into metabolic equivalent of task (MET).
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Current mental health: Subjective Vitality Index
The Subjective Vitality Scale is a 7-item self-report instrument to measure one's level of vitality. The score is calculated by assigning scores of 1-7 to the response categories from "not at all true," "somewhat true," to "very true,", and then adding together the scores for the seven questions. The total score for the seven items ranges from 0 to 21. The higher the participants scored, the better vitality the participants had.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Self-confidence for exercise: Self-Efficacy for Exercise (SEE) Scale
This scale is a 9-item self-report of exercise self-efficacy. Total score is calculated by summing the responses to each question, assigning scores of 1-10 to the response categories from "not confident," to "very confident,". This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Self-confidence for exercise: Perceived Competence for Exercise Scale
This scale is a 4-item self-report of exercise self-efficacy. Total score is calculated by summing the responses to each question, assigning scores of 1-7 to the response categories from "not at all true," "somewhat true," to "very true,". This scale has a range of total scores from 0-28. A higher score indicates higher self-efficacy for exercise.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Attitudes to exercise: Multidimensional Outcome Expectations for Exercise Scale (MOEES)
This scale is a 15-item self-report of one's beliefs or expectations about the benefits of regular exercise or physical activity. Total score is calculated by summing the responses to each question, assigning scores of 1-5 to the response categories from "strongly disagree," "neutral," to "strongly agree,". A higher score indicates greater positive attitudes to exercise.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Attitudes to exercise: the Self-Report Habit Index
This scale is a 12-item self-report of one's beliefs about the benefits of exercise. Total score is calculated by summing the responses to each question, assigning scores of 1-7 to the response categories from "not at all true," "somewhat true," to "very true,". A higher score indicates greater positive attitudes to exercise.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Acceptability of the intervention: Theoretical framework of acceptability questionnaire
Acceptability was measured with an 8-item questionnaire based on the dimensions of the theoretical framework of acceptability (TFA). Total score is calculated by summing the responses to each question, assigning scores of 1-5 to the response categories from "completely unacceptable," "no opinion," to "completely acceptable,". A higher score indicates greater acceptability to the exercise programme.
Measured: 12-weeks (week 4, week 8, week 12)
General health: Short Form Health Survey (SF-36)
The SF-36 is a multi-purpose survey designed to capture participants perceptions of their own health and well-being. The SF-36 has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. It includes combinations of 5-point scales, 3-point scales, and dichotomous (yes/no) items. The instrument's scores are norm-based: a score of 50 = average. A higher score indicates greater health condition ones have.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Mental health and wellbeing: the Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)
A 14-item scale with subjective wellbeing and psychological functioning questions for assessing mental health. The score is calculated by assigning scores of 1-5 to the response categories from "none of the time," "some of the time," to "all of the time,", and then adding together the scores for the 14 questions. The total score ranges from 14 to 70. The higher the participants scored, the better wellbeing the participants had.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Quality of life: EQ-5D-5L
EQ-5D-5L has 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and one subjective EQ VAS score, which is a 0-100 scale where participants were asked to score their overall health on the day of questionnaire completion. regarding the 5 dimensions, the score is assessed by assigning scores of levels 1-5 to the response indicates from no problem, slight to moderate problems, to severe problems, and unable to/extreme problems.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Attitudes to exercise: the Behaviour Regulation Exercise Questionnaire (BREQ-3)
A 24-item self-report of one's attitudes toward exercise underlying self-determination theory. It indicates amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic regulation toward exercise, using 4-point scales from 0-4 to the response categories from "not true for me," to "very true for me,". The higher the score ones get, the more positive attitudes for exercise ones have.
Measured: 12-weeks (week 0, week 4, week 8, week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start20 May 2022
- Primary completion23 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian-Ju Liang, University of Bath
- Investigators
- Max Western, Study chair, Department for Health, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758727
- Sponsor's protocol ID
- EP 20/21 082
- Status last verified
- Aug 2023
- First submitted
- 15 Feb 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Home-based Strength and Tai-chi Exercise Snacking for Improving Physical Function in Taiwanese and British Older Adults: a Randomised Control Trial.
- ClinicalTrials.gov ID
- NCT05758727
- Acronym / sponsor ID
- EP 20/21 082
- Conditions
- Older Adults
- Keywords
- Exercise snacking, Tai-chi snacking, Older adults, Homebased exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Engaging in muscle strength and balance (S\&B) exercises and has numerous health benefits for older adults, promoting greater mobility, reducing risk of falling, and overall improved health and wellbeing. Given the rising age of global populations, reducing the burden associated with lost physical function is essential to minimise health and social care costs. Unfortunately, very few older adults engage in sufficient S\&B exercise to reap these benefits, with a lack of time, self-efficacy and access to leisure facilities cited as the key barriers. Finding innovative ways promote an acceptable and engaging format of S\&B exercise is consequently a public health priority.
One novel way that aims to address typical barriers to participation in older adults is through the promotion of exercise 'snacks', as opposed to a more traditional, lengthy structured exercise session at a leisure centre. Exercise snacking describes short bursts of exercise that are designed to be undertaken over a short period in the home environment and without the need for any specialised exercise clothing or equipment. In the initial laboratory and cross-sectional and pilot intervention research, the investigators have been testing two formats of 5-minute, twice-daily, strength exercise- and tai-chi-snacking, which has been shown to be acceptable and feasible to implement in older adults. This protocol presents initial efficacy for evoking improved physical function in people aged 65 years or more. The investigators' remote study demonstrated that remote assessment and delivery of 4-week exercise and tai-chi snacking interventions were acceptable and feasible. However, qualitative feedback indicated that exercise programmes may be more acceptable and interesting with simpler tai-chi movements and exercise snacking programme with upper body movements. Nevertheless, the investigators only recruited healthy older adults, doing short-term interventions in previous studies. This study aims to test the effectiveness of progressive S\&B interventions over a sustained period in pre-frail older adults.
Detailed description
This study will take place over approximately 3 months and involve 5 assessments remotely. A subset of 60 participants will be assessed in person to validate the remote assessment and undergo more in-depth assessments.
Assessment 1: Familiarisation Participants will be directed to a web page with the participant information sheet and a consent tick box. Participants will then complete an online screening questionnaire that will assess eligibility. After this, participants will undertake a familiarisation session either online (all participants) or in person (lab participants only) to become accustomed to the physical function tests and undergo an exercise safety assessment.
Assessment 2: Baseline assessment. After familiarisation, eligible participants will then complete an online baseline questionnaire assessing demographic details, physical activity levels and psychological outcomes. A functional assessment will be arranged over video calling software, and in the laboratory for the lab participants. Functional outcomes will be completed at this visit. Following the baseline assessment participants will be randomised to either the intervention group, or the waitlist control group.
Assessment 3 and 4: Mid intervention. Participants in the intervention group will be given an exercise teaching video and written instructions on how to safely perform the exercise at home by email. The intervention will take place over 12 weeks and consists of three progressive phases that will be self-selected by participants. The participants will be asked to do the exercises and progress to the next level if they pass the progress criteria which will be clearly explained in the exercise guides and instructional videos. The participants will also be asked to record self-reported exercise logs and RPE for each session they complete. Participants will undergo follow-up assessments at weeks 4 and 8 through video calls and in person (if in the lab study).
Assessment 5: Follow-up assessment. After 12 weeks, participants will complete another online survey containing all psychosocial variables and an evaluation of the usefulness and acceptability of their assigned exercise activities. Participants will also undergo follow-up physical performance tests through video calls and in person (if in the lab study) and a subset will undergo a qualitative evaluation to provide further feedback on the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based exercise group | Experimental | Other: Exercise interventionThis group will be asked to practise the 'exercise snacking and Tai-chi snacking' exercises once each and record the exercise bouts in a log book. |
| Control group | No intervention | –Usual care control group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- People aged 65 or greater and are able to perform daily physical activity independently.
- Not regularly engaging in recreational sports or structured exercise (once a week or more).
- Citizen of UK or Taiwan.
- Individuals who are able to do the 5 reps sit-to-stand in less than 60s and the feet side-by-side stand for at least 10s, following the initial safety screening.
Key exclusion criteria (6 listed)
- Individuals with current ongoing medication or treatment for injuries or illness that would impact on any of the study outcomes.
- Individuals with a current musculoskeletal injury that would preclude participation in exercise ascertained through preliminary screening.
- Individuals with contraindications to exercise including chest pain, dizziness, or loss of consciousness, or who have been instructed by their doctor to only do physical activity recommended by them.
- Individuals who have been diagnosed with dementia.
- Individuals who are unable to consent for themselves or complete the familiarisation / baseline screening by themselves.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionThe exercise programme is progressive and has three levels. Each bout of exercise and Tai-chi snacking consists of 5 exercises. Each exercise is performed for one minute with one minute rest in between. For exercise snacking movements (including leg exercise, shoulder exercise, single leg exercise, arm exercise, and ankle exercise), participants are encouraged to complete as many repetitions as possible of that exercise in that minute. For Tai-chi snacking movements (including single leg squat, trunk rotation, single leg stand, hip and knee exercise, and ankle mobility exercise), participants are encouraged to complete repetitions of each exercise at a self-selected pace that is comfortable for them to maintain for the full minute, with the aim being to complete the movements as accurately and smoothly as possible (based on correct posture and proper alignment). | Other | Home-based exercise group |
Primary outcome
Changes of Short Physical Performance Battery (SPPB) between every 4 weeks
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Participants will be asked to do the SPPB test which includes balance test, gait speed test, and chair stand test.
18 secondary outcomes
1RM of leg press
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Balance function
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Strength function
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Agility function
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Flexibility
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Quality of life and wellbeing: Life Satisfaction Scale
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Physical activity level: the instrumental activities of daily living (IADL)
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Physical activity level: the International Physical Activity Questionnaire for elderly (IPAQ-E) (short form)
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Current mental health: Subjective Vitality Index
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Self-confidence for exercise: Self-Efficacy for Exercise (SEE) Scale
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Self-confidence for exercise: Perceived Competence for Exercise Scale
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Attitudes to exercise: Multidimensional Outcome Expectations for Exercise Scale (MOEES)
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Attitudes to exercise: the Self-Report Habit Index
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Acceptability of the intervention: Theoretical framework of acceptability questionnaire
Time frame: 12-weeks (week 4, week 8, week 12)
General health: Short Form Health Survey (SF-36)
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Mental health and wellbeing: the Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Quality of life: EQ-5D-5L
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Attitudes to exercise: the Behaviour Regulation Exercise Questionnaire (BREQ-3)
Time frame: 12-weeks (week 0, week 4, week 8, week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Western study chair
Department for Health, University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Older Adults, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Short Physical Performance Battery (SPPB) between every 4 weeks (time frame: 12-weeks (week 0, week 4, week 8, week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.