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Vitality Oriented Innovation for the Lifecourse of the Ageing Society - Intervention Study

Vitality Oriented Innovation for the Lifecourse of the Ageing Society - Intervention Study - VOILA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54190
Enrollment
220
Registered
2021-10-20
Start date
2022-04-26
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

veroudering (immunometabool, darmgezondheid, spiergezondheid/functioneren) Ageing getting older

Interventions

The intervention consists of a combined exercise and nutritional intervention. All participants will perform 12 weeks of supervised whole-body resistance type exercise training
leg press, leg extension, calf raises, chest press, shoulder press, horizontal row and vertical lateral pull exercise will be performed on weightlifting machines, 3 days per week. The dietary interv

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
65 Years to 99 Years

Inclusion criteria

Inclusion criteria: All participants: age 60 or older, body mass index 18.5-35.0 kg/m2, community-dwelling, mentally competent (MMSE score 24 or over). Depending on the group the main additional criteria are: 1) metabolically compromised group: Metabolomic Mortality Score within the top half of the batch of subjects 60 years and older from and also outside the LLS cohort 2) mobility compromised group: using a walking aid and/or slow 5-times chair stand test (>15 seconds) 3) total knee replacement groups (intervention group and control group): living in/or around the areas of Maastricht, Eindhoven, and Venlo/Roermond/Nijmegen and underwent elective total knee replacement surgery ~6 weeks before start of study 4) healthy active reference group: meeting the Dutch norms for being physically active, Metabolic Mortality Score below the top half of of the batch of subjects 60 years and older from and also outside the LLS cohort

Exclusion criteria

Exclusion criteria: Already using prebiotic fibres or high doses of supplements, contraindications for using milk/lactose/calcium/vitamin D, engagement in intense physical activity, (aforementioned criteria are not exclusion criteria for the reference group), eGFR

Design outcomes

Primary

MeasureTime frame
The main study endpoints are the intervention effects on metabolic outcomes (glucose, glycoprotein acetyl, very low-density lipoprotein diameter), faecal bifidobacterial count, time for the 5-times chair stand test and appendicular lean mass in the intervention groups.

Secondary

MeasureTime frame
The secondary study parameters are: - Muscle function: Short Physical Performance Battery (SPPB), Timed Up and Go test (TUG), 6-minute walking test (6MWT), 1 repetition maximum test (1RM) as measured on exercise machines - Body composition: DEXA whole body and regional lean and fat mass - Immuno-metabolic health: haemoglobin A1c (Hba1c), insulin, blood pressure - Specifically for the TKR group, additional measures will be performed to assess muscle mass and overall functioning following TKR-surgery: a single-slice CT-scans midway the upper legs, and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). - Response heterogeneity (and potential explaining factors) will be studied using the above primary and secondary parameters and may be studied in the future in RNA expression, DNA methylation as well as the influence of genetic variation in the metabolically impaired groups and the reference group and be compared with such studies in other lifestyle interventions in older adults .

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)