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Does Exercise Snacking Improve Muscle Function in Older Adults?

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ClinicalTrials.gov Identifier: NCT02991989
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Mr Oliver Perkin, University of Bath

Tracking Information
First Submitted Date  ICMJE December 6, 2016
First Posted Date  ICMJE December 14, 2016
Last Update Posted Date May 23, 2018
Actual Study Start Date  ICMJE November 20, 2016
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02991989 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2016)
  • Lower limb muscle power [ Time Frame: 28 days- change from pre- to post- intervention period ]
    Measured during leg pressing
  • Lower limb movement outcome variability [ Time Frame: 28 days- change from pre- to post- intervention period ]
    Measured during leg pressing
  • Lower limb muscle cross-sectional area [ Time Frame: 28 days- change from pre- to post- intervention period ]
    Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length
  • Lower limb muscle cross-sectional tissue density [ Time Frame: 28 days- change from pre- to post- intervention period ]
    Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length
  • Body composition [ Time Frame: 28 days- change from pre- to post- intervention period ]
    Measured using Dual Energy X-ray Absorptiometry
  • Gastrocnemius and quadriceps muscle fibre pennation angle [ Time Frame: 28 days- change from pre- to post- intervention period ]
    Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length
  • Gastrocnemius and quadriceps muscle fibre length [ Time Frame: 28 days- change from pre- to post- intervention period ]
    Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length
  • Postural sway during standing balance with eyes open and closed [ Time Frame: 28 days- change from pre- to post- intervention period ]
    Measured using a force plate
  • Single leg balance [ Time Frame: 28 days- change from pre- to post- intervention period ]
    Measured using the Y-balance test
  • Six minute walk test [ Time Frame: 28 days- change from pre- to post- intervention period ]
    The participant will be asked to walk as many times between two cones places 15 meters apart as possible in six minutes.
  • Movement co-ordination during walking and sit to stands [ Time Frame: 28 days- change from pre- to post- intervention period ]
    Measured by Qualisys motion capture and force plates
  • Central drive of the plantar flexors [ Time Frame: 28 days- change from pre- to post- intervention period ]
    Measured through the interpolated twitch technique
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Exercise Snacking Improve Muscle Function in Older Adults?
Official Title  ICMJE Does Exercise Snacking Improve Muscle Function in Older Adults?
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Muscle Function
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Exercise Snacking
    • Dietary Supplement: Yogurt
  • 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.
    Intervention: Dietary Supplement: Yogurt
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2018)
20
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2016)
40
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02991989
Other Study ID Numbers  ICMJE UoB-ESS-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers
Responsible Party Mr Oliver Perkin, University of Bath
Study Sponsor  ICMJE University of Bath
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Keith Stokes, PhD University of Bath
PRS Account University of Bath
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP