NCT02991989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

December 6, 2016

Last Update Submit

May 21, 2018

Conditions

Keywords

Home-based exerciseExercise snackingProteinYogurt

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Lower limb muscle power

    28 days- change from pre- to post- intervention period

  • Lower limb movement outcome variability

    28 days- change from pre- to post- intervention period

  • Lower limb muscle cross-sectional area

    28 days- change from pre- to post- intervention period

  • Lower limb muscle cross-sectional tissue density

    28 days- change from pre- to post- intervention period

  • Body composition

    28 days- change from pre- to post- intervention period

  • +7 more secondary outcomes

Study Arms (2)

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.

Behavioral: Exercise SnackingDietary 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.

Dietary Supplement: Yogurt

Interventions

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.

Exercise Snacking Group
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.

Exercise Snacking GroupYogurt Only Group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, Avon, BA2 7AY, United Kingdom

Location

MeSH Terms

Interventions

Yogurt

Intervention Hierarchy (Ancestors)

Cultured Milk ProductsMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Officials

  • Keith Stokes, PhD

    University of Bath

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 14, 2016

Study Start

November 20, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

May 23, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers

Locations