Muscle FunctionNCT02991989
Does Exercise Snacking Improve Muscle Function in Older Adults?
A study testing Exercise Snacking and Yogurt in people with Muscle Function, run by University of Bath at 1 site in United Kingdom.
Trial summary
Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength declining up to twice as fast as muscle size. This may eventually lead to loss of independence if tasks of daily living become too strenuous to be performed safely. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Function
- What is being tested?
- Exercise Snacking and Yogurt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Nov 2016to Jul 2017
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Not underweight or obese (body mass index ≥20 and ≤ 30 kg/m2)
- Not regularly engaging in recreational sports or structured exercise (once a week or more).
- Non-smoker (for >5 years)
- Healthy (see exclusion criteria)
Who cannot join
- Any chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, peripheral arterial disease, insulin- or non-insulin dependent diabetes or other metabolic disorders - all ascertained through preliminary screening.
- Individuals with a history of bone, joint or neuromuscular problems or a current musculoskeletal injury ascertained through preliminary screening.
- Individuals with any joint replacement surgical implants or other artifacts containing metal.
- Individuals with a clinically diagnosed allergy or intolerance of dairy products.
- 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 score less than 8 on the Short Physical Performance Battery or score zero on any component of the test.
Trial locations and contacts
1 site in 1 country.
About this study
Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength declining up to twice as fast as muscle size. This may eventually lead to loss of independence if tasks of daily living become too strenuous to be performed safely. Exercise is recognized as a safe and effective means to counteract muscle loss during aging, however access to gym equipment may be logistically challenging or unpalatable to older adults. This research is designed to investigate the effect of 28 days of home-based leg exercise that doesn't require exercise equipment or supervision (exercise snacking), accompanied with a daily protein supplement in the form of commercially available yogurt, on the skeletal muscle health (i.e. function and size) of independent, community-dwelling older adults. To achieve this, two groups will be compared; one group will undertake exercise snacking and consume a 150 g yogurt with the breakfast meal for four weeks, with the second group only receiving the daily yogurt with no exercise snacking.
Read the detailed description
The study will require potential participants to undergo an eligibility screening with a member of the research team, followed by a period of seven days of habitual activity monitoring and 3 days of diet recording. Eligible participants will be allocated into study groups by way of minimization based on sex, age, BMI, and number of sit-to-stands performed in a minute. Participants will undertake two familiarisation sessions with strength, power, neural drive, and balance tests at least seven days apart, the first following eligibility screening and the second familiarisation session at least five days before the first main trial.
Thereafter, both groups will undertake a main trial the day before commencing 28 days of daily 150 g yoghurt supplement with the breakfast meal, with the exercise snacking group (ES) also undertaking two bouts of exercise snacking a day. The main trial will include measures of leg muscle function and neural drive, standing and single leg balance, and movement co-ordination during tasks of everyday ambulation. Participants will wear a physical activity monitor and pedometer for the seven days and record diet for three days during the last week of the intervention. The day after the intervention period, a follow-up main trial will be conducted as per the first main trial, followed by an optional qualitative interview regarding participant's experience of the trial.
- Conditions
- Muscle Function
- Being tested
- Exercise Snacking, Yogurt
- Keywords
- Home-based exercise, Exercise snacking, Protein, Yogurt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise SnackingBehavioural
Each bout of exercise snacking consists of 5 exercise. Each exercise is performed for one minute, with aim of completing as many repetitions as possible of that exercise in that minute. One minute of rest is observed between each exercise of the exercise snack. The five exercises are; sit-to-stand from a chair, marching on the spot, seated knee extensions alternating legs, standing knee bends alternating legs, and standing calf raises. The sit-to-stand exercise is always performed first, with the number of repetitions achieved recorded, and subsequent exercises performed in any order without recording of repetitions.
Two exercise snacks are completed each day for 28 days; once in the morning and once in the evening, or at least separated by 2 hours.
YogurtDietary supplement
Participants are asked to consume 150 g of yogurt (Arla, Skyr- natural flavour) with their breakfast meal. Participants may substitute the yogurt for another part of their regular breakfast, or add the yogurt to their regular breakfast, with participants asked to record a log book of daily yogurt consumption and to complete a three day food diary during the last week of the 28 day intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Snacking Group | Experimental | For 28 days, this group will be asked to perform two 'exercise snacks' a day; once in the morning and once in the evening. They will also be asked to consume 150 g of yogurt with the breakfast meal. The yogurt will be provided by the researchers. Receives: Behavioral: Exercise Snacking; Dietary Supplement: Yogurt |
| Yogurt Only Group | Other | For 28 days, this group will be asked to consume 150 g of yogurt with the breakfast meal. The yogurt will be provided by the researchers. Apart from consuming the yogurt, this group will be asked to continue their normal lifestyle. Receives: Dietary Supplement: Yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
60 second sit to stand test
The participant is asked to stand up from sitting in a chair whilst keeping their arms folded across their chest, then return to the seated position as many times as possible in a minute.
Measured: 28 days- change from pre- to post- intervention period
Secondary outcomes (12)
Lower limb muscle power
Measured during leg pressing
Measured: 28 days- change from pre- to post- intervention period
Lower limb movement outcome variability
Measured during leg pressing
Measured: 28 days- change from pre- to post- intervention period
Lower limb muscle cross-sectional area
Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length
Measured: 28 days- change from pre- to post- intervention period
Lower limb muscle cross-sectional tissue density
Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length
Measured: 28 days- change from pre- to post- intervention period
Body composition
Measured using Dual Energy X-ray Absorptiometry
Measured: 28 days- change from pre- to post- intervention period
Gastrocnemius and quadriceps muscle fibre pennation angle
Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length
Measured: 28 days- change from pre- to post- intervention period
Gastrocnemius and quadriceps muscle fibre length
Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length
Measured: 28 days- change from pre- to post- intervention period
Postural sway during standing balance with eyes open and closed
Measured using a force plate
Measured: 28 days- change from pre- to post- intervention period
Single leg balance
Measured using the Y-balance test
Measured: 28 days- change from pre- to post- intervention period
Six minute walk test
The participant will be asked to walk as many times between two cones places 15 meters apart as possible in six minutes.
Measured: 28 days- change from pre- to post- intervention period
Movement co-ordination during walking and sit to stands
Measured by Qualisys motion capture and force plates
Measured: 28 days- change from pre- to post- intervention period
Central drive of the plantar flexors
Measured through the interpolated twitch technique
Measured: 28 days- change from pre- to post- intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start20 Nov 2016
- Primary completion1 Jun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FunctionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Oliver Perkin, University of Bath
- Investigators
- Keith Stokes, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991989
- Sponsor's protocol ID
- UoB-ESS-01
- Status last verified
- May 2018
- First submitted
- 6 Dec 2016
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Exercise Snacking Improve Muscle Function in Older Adults?
- ClinicalTrials.gov ID
- NCT02991989
- Acronym / sponsor ID
- UoB-ESS-01
- Conditions
- Muscle Function
- Keywords
- Home-based exercise, Exercise snacking, Protein, Yogurt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 20 Nov 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 14 Dec 2016 (estimated)
- 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.
Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength declining up to twice as fast as muscle size. This may eventually lead to loss of independence if tasks of daily living become too strenuous to be performed safely. Exercise is recognized as a safe and effective means to counteract muscle loss during aging, however access to gym equipment may be logistically challenging or unpalatable to older adults. This research is designed to investigate the effect of 28 days of home-based leg exercise that doesn't require exercise equipment or supervision (exercise snacking), accompanied with a daily protein supplement in the form of commercially available yogurt, on the skeletal muscle health (i.e. function and size) of independent, community-dwelling older adults. To achieve this, two groups will be compared; one group will undertake exercise snacking and consume a 150 g yogurt with the breakfast meal for four weeks, with the second group only receiving the daily yogurt with no exercise snacking.
Detailed description
The study will require potential participants to undergo an eligibility screening with a member of the research team, followed by a period of seven days of habitual activity monitoring and 3 days of diet recording. Eligible participants will be allocated into study groups by way of minimization based on sex, age, BMI, and number of sit-to-stands performed in a minute. Participants will undertake two familiarisation sessions with strength, power, neural drive, and balance tests at least seven days apart, the first following eligibility screening and the second familiarisation session at least five days before the first main trial.
Thereafter, both groups will undertake a main trial the day before commencing 28 days of daily 150 g yoghurt supplement with the breakfast meal, with the exercise snacking group (ES) also undertaking two bouts of exercise snacking a day. The main trial will include measures of leg muscle function and neural drive, standing and single leg balance, and movement co-ordination during tasks of everyday ambulation. Participants will wear a physical activity monitor and pedometer for the seven days and record diet for three days during the last week of the intervention. The day after the intervention period, a follow-up main trial will be conducted as per the first main trial, followed by an optional qualitative interview regarding participant's experience of the trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Snacking Group | Experimental | Behavioral: Exercise Snacking, Dietary Supplement: YogurtFor 28 days, this group will be asked to perform two 'exercise snacks' a day; once in the morning and once in the evening. They will also be asked to consume 150 g of yogurt with the breakfast meal. The yogurt will be provided by the researchers. |
| Yogurt Only Group | Other | Dietary Supplement: YogurtFor 28 days, this group will be asked to consume 150 g of yogurt with the breakfast meal. The yogurt will be provided by the researchers. Apart from consuming the yogurt, this group will be asked to continue their normal lifestyle. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Not underweight or obese (body mass index ≥20 and ≤ 30 kg/m2)
- Not regularly engaging in recreational sports or structured exercise (once a week or more).
- Non-smoker (for >5 years)
- Healthy (see exclusion criteria)
Key exclusion criteria (6 listed)
- Any chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, peripheral arterial disease, insulin- or non-insulin dependent diabetes or other metabolic disorders - all ascertained through preliminary screening.
- Individuals with a history of bone, joint or neuromuscular problems or a current musculoskeletal injury ascertained through preliminary screening.
- Individuals with any joint replacement surgical implants or other artifacts containing metal.
- Individuals with a clinically diagnosed allergy or intolerance of dairy products.
- 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.
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 SnackingEach bout of exercise snacking consists of 5 exercise. Each exercise is performed for one minute, with aim of completing as many repetitions as possible of that exercise in that minute. One minute of rest is observed between each exercise of the exercise snack. The five exercises are; sit-to-stand from a chair, marching on the spot, seated knee extensions alternating legs, standing knee bends alternating legs, and standing calf raises. The sit-to-stand exercise is always performed first, with the number of repetitions achieved recorded, and subsequent exercises performed in any order without recording of repetitions. Two exercise snacks are completed each day for 28 days; once in the morning and once in the evening, or at least separated by 2 hours. | Behavioural | Exercise Snacking Group |
| YogurtParticipants are asked to consume 150 g of yogurt (Arla, Skyr- natural flavour) with their breakfast meal. Participants may substitute the yogurt for another part of their regular breakfast, or add the yogurt to their regular breakfast, with participants asked to record a log book of daily yogurt consumption and to complete a three day food diary during the last week of the 28 day intervention period. | Dietary supplement | Exercise Snacking Group, Yogurt Only Group |
Primary outcome
60 second sit to stand test
Time frame: 28 days- change from pre- to post- intervention period
The participant is asked to stand up from sitting in a chair whilst keeping their arms folded across their chest, then return to the seated position as many times as possible in a minute.
12 secondary outcomes
Lower limb muscle power
Time frame: 28 days- change from pre- to post- intervention period
Lower limb movement outcome variability
Time frame: 28 days- change from pre- to post- intervention period
Lower limb muscle cross-sectional area
Time frame: 28 days- change from pre- to post- intervention period
Lower limb muscle cross-sectional tissue density
Time frame: 28 days- change from pre- to post- intervention period
Body composition
Time frame: 28 days- change from pre- to post- intervention period
Gastrocnemius and quadriceps muscle fibre pennation angle
Time frame: 28 days- change from pre- to post- intervention period
Gastrocnemius and quadriceps muscle fibre length
Time frame: 28 days- change from pre- to post- intervention period
Postural sway during standing balance with eyes open and closed
Time frame: 28 days- change from pre- to post- intervention period
Single leg balance
Time frame: 28 days- change from pre- to post- intervention period
Six minute walk test
Time frame: 28 days- change from pre- to post- intervention period
Movement co-ordination during walking and sit to stands
Time frame: 28 days- change from pre- to post- intervention period
Central drive of the plantar flexors
Time frame: 28 days- change from pre- to post- intervention period
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 23 May 2018.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
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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.
Keith Stokes, PhD principal investigator
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 Snacking and Yogurt in people with Muscle Function, 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 23 May 2018. 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?
60 second sit to stand test (time frame: 28 days- change from pre- to post- intervention period). 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 23 May 2018.