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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02991989
Other study ID # UoB-ESS-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2016
Est. completion date July 2017

Study information

Verified date May 2018
Source University of Bath
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 2017
Est. primary completion date June 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise Snacking
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.
Dietary Supplement:
Yogurt
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.

Locations

Country Name City State
United Kingdom University of Bath Bath Avon

Sponsors (1)

Lead Sponsor Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 28 days- change from pre- to post- intervention period
Secondary Lower limb muscle power Measured during leg pressing 28 days- change from pre- to post- intervention period
Secondary Lower limb movement outcome variability Measured during leg pressing 28 days- change from pre- to post- intervention period
Secondary Lower limb muscle cross-sectional area Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length 28 days- change from pre- to post- intervention period
Secondary 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 28 days- change from pre- to post- intervention period
Secondary Body composition Measured using Dual Energy X-ray Absorptiometry 28 days- change from pre- to post- intervention period
Secondary Gastrocnemius and quadriceps muscle fibre pennation angle Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length 28 days- change from pre- to post- intervention period
Secondary Gastrocnemius and quadriceps muscle fibre length Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length 28 days- change from pre- to post- intervention period
Secondary Postural sway during standing balance with eyes open and closed Measured using a force plate 28 days- change from pre- to post- intervention period
Secondary Single leg balance Measured using the Y-balance test 28 days- change from pre- to post- intervention period
Secondary 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. 28 days- change from pre- to post- intervention period
Secondary Movement co-ordination during walking and sit to stands Measured by Qualisys motion capture and force plates 28 days- change from pre- to post- intervention period
Secondary Central drive of the plantar flexors Measured through the interpolated twitch technique 28 days- change from pre- to post- intervention period
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