- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02991989
Does Exercise Snacking Improve Muscle Function in Older Adults?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Avon
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Bath, Avon, United Kingdom, BA2 7AY
- University of Bath
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Exercise Snacking Group
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.
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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.
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.
|
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Other: Yogurt Only Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
60 second sit to stand test
Time Frame: 28 days- change from pre- to post- intervention period
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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.
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28 days- change from pre- to post- intervention period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower limb muscle power
Time Frame: 28 days- change from pre- to post- intervention period
|
Measured during leg pressing
|
28 days- change from pre- to post- intervention period
|
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Lower limb movement outcome variability
Time Frame: 28 days- change from pre- to post- intervention period
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Measured during leg pressing
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28 days- change from pre- to post- intervention period
|
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Lower limb muscle cross-sectional area
Time Frame: 28 days- change from pre- to post- intervention period
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Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length
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28 days- change from pre- to post- intervention period
|
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Lower limb muscle cross-sectional tissue density
Time Frame: 28 days- change from pre- to post- intervention period
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Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length
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28 days- change from pre- to post- intervention period
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Body composition
Time Frame: 28 days- change from pre- to post- intervention period
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Measured using Dual Energy X-ray Absorptiometry
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28 days- change from pre- to post- intervention period
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Gastrocnemius and quadriceps muscle fibre pennation angle
Time Frame: 28 days- change from pre- to post- intervention period
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Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length
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28 days- change from pre- to post- intervention period
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Gastrocnemius and quadriceps muscle fibre length
Time Frame: 28 days- change from pre- to post- intervention period
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Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length
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28 days- change from pre- to post- intervention period
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Postural sway during standing balance with eyes open and closed
Time Frame: 28 days- change from pre- to post- intervention period
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Measured using a force plate
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28 days- change from pre- to post- intervention period
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Single leg balance
Time Frame: 28 days- change from pre- to post- intervention period
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Measured using the Y-balance test
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28 days- change from pre- to post- intervention period
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Six minute walk test
Time Frame: 28 days- change from pre- to post- intervention period
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The participant will be asked to walk as many times between two cones places 15 meters apart as possible in six minutes.
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28 days- change from pre- to post- intervention period
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Movement co-ordination during walking and sit to stands
Time Frame: 28 days- change from pre- to post- intervention period
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Measured by Qualisys motion capture and force plates
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28 days- change from pre- to post- intervention period
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Central drive of the plantar flexors
Time Frame: 28 days- change from pre- to post- intervention period
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Measured through the interpolated twitch technique
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28 days- change from pre- to post- intervention period
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Keith Stokes, PhD, University of Bath
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UoB-ESS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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