Sarcopenia Musculoskeletal Diseases Sarcopenia
Conditions
Interventions
Current interventions as of 11/02/2019:
Thirty eligible participants (15 men and 15 women) will be stratified by gender (male, female) and age (aged 65-74 and 75+) and randomised into
Ocean Spray Classic) will be balanced to match the energy content of whole milk, and will be supplemented with maltodextrin (6.05 g
Sponsors
Northumbria Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 11/02/2019: 1. Aged =65 years 2. Living in the community 3. Registered patient with one of the general practice (GP) surgeries in North East and North Cumbria CRN (lead: Laura Renwick, Research Operation Officer). Previous inclusion criteria: 1. Aged =65 years 2. Living in the community 3. Registered patient with one of the general practice (GP) surgeries in North East and North Cumbria CRN (lead: Laura Renwick, Research Operation Officer). 4. Low grip strength (<20 kg in women, and <30 kg in men) or slow walking speed (<0.8 m/s or =5 s over 4 m distance), which are established components of sarcopenia (this will be established at the screening assessment at participants' home)
Exclusion criteria
Exclusion criteria: 1. Living in care homes (residential or nursing) 2. Lacks capacity to consent 3. Self-reported lactose intolerance or milk allergies 4. Dislikes milk 5. Unable to understand instructions for muscle strength and function assessments in English or unwilling to participate in protocol when explained 6. Dislikes gym exercise with equipment 7. Doctor diagnosed diabetes I and II 8. Doctor diagnosed impaired renal function (estimated glomerular filtration rate <30 ml/min/1.73m²) 9. Doctor diagnosed liver function impairment, including viral hepatitis, alcoholic hepatitis, liver cirrhosis, biliary obstruction, non-alcoholic fatty liver disease, ischemic liver injury 10. Significant respiratory disease, including COPD, severe asthma, and bronchitis 11. Doctor diagnosed gastrointestinal tract disease, including gastritis, peptic ulceration, inflammatory bowel disease, gastric carcinoma, pancreas disease 12. History of neuromuscular problems and all other co-morbidities that substantially interact with mobility and muscle metabolism, including severe arthritis, rigidity, paralysis 13. Pacemaker or severe heart failure or any other significant heart disease 14. Uncontrolled hypertension (160/100) and uncontrolled hypotension (<100 systolic) 15. Hip or knee replacement 16. BMI =30 kg/m² 17. Unintentional weight loss =5 kg for the last 3 months 18. Taking warfarin 19. Structured resistance exercise training and gym-based programme in last month 20. An individual who the General Practitioner feels it is inappropriate for the researchers to approach — the general practitioner has detailed knowledge of patients and may consider individual unsuitable for approach for reasons such as end stage terminal disease or safety risk such as any physical and medical conditions that preclude safe participation in an exercise programme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of feasibility and acceptability of the study including: 1. Feasibility of identification and recruitment of community-based participants, assessed using a statistical calculation of the percentage of patients screened through general practices data base that meet exclusion and inclusion criteria. This calculation is completed before participant randomisation into control and intervention groups 2. The willingness of community-based participants to participate, assessed using a statistical calculation of the number and percentage of participants who returned reply slips with ‘yes’ answer expressing their interest in the study out of 200 participants’ packs sent. This calculation is completed before screening home-based interview 3. The practicality of delivering assessments/intervention in the proposed setting (participants home and community gym), assessed through feedback from participants and research assistants experiences during an interview using structured and open-ended questions at the post-intervention home visit (after 6 weeks of intervention) 4. Acceptability of the assessment and intervention (whole milk and resistance exercise) to participants, assessed using a post-intervention interview using structured multiple-response questions and standardised open-ended questions 5. Response rates (percentage) to questionnaires, assessments and intervention at home-based screen interview, baseline and post-intervention interview 6. Attrition rate between baseline and 12 consecutive intervention visits to a local gym (The Parks), assessed using a statistical calculation of the percentage of participants dropping out from baseline to intervention visit 6, and from baseline to intervention visit 12 7. Time needed to collect and analyse data (total time in days and months), assessed using a statistical calculation of the total time in days from the | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/02/2019: 1. Usefulness of the SARC-F measured at pre-screening by comparison to measures of grip strength and walking speed measured at screening. Exploratory analysis of within and between-group differences in: 2. Physical functioning, measured using the Short Physical Performance Battery (SPPB) comprising of balance test, 4m-gait speed, and 5-chair stands at the baseline and after 6 weeks of intervention (post-intervention home-based interview) 3. Muscle strength (maximum strength test), measured as grip strength using a hand-held dynamometer at the baseline and after 6 weeks of intervention (post-intervention home-based interview) 4. Body composition, measured using bioelectrical impedance analysis (BIA) (body weight, BMI, muscle mass, fat mass) at the baseline and after 6 weeks of intervention (post-intervention interview) 5. Self-reported quality of life, assessed using the 12-item Short Form Survey (SF-12) at the baseline and after 6 weeks of intervention (post-intervention interview) 6. Activities of daily living, assessed using the Barthel Index at the baseline and after 6 weeks of intervention (post-intervention interview) Previous secondary outcome measures: Exploratory analysis of within and between group differences in: 1. Physical functioning, measured using the Short Physical Performance Battery (SPPB) comprising of balance test, 4m-gait speed, and 5-chair stands at the baseline and after 6 weeks of intervention (post-intervention home-based interview) 2. Muscle strength (maximum strength test), measured as grip strength using a hand-held dynamometer at the baseline and after 6 weeks of intervention (post-intervention home-based interview) 3. Body composition, measured using bioelectrical impedance analysis (BIA) (body | — |
Countries
England, United Kingdom
Outcome results
None listed