DO-HEALTH / Vitamin D3 - Omega3 - Home Exercise - Healthy Ageing and Longevity Trial
- Conditions
- Improve Healthy Ageing in Seniors; Prevent Disease at Older Age
- Interventions
- Procedure: Strength Home ExerciseProcedure: Flexibility Home Exercise
- Registration Number
- NCT01745263
- Lead Sponsor
- University of Zurich
- Brief Summary
The European population is aging rapidly which poses a challenge on the individual, the European societies, and health care systems. Among the most promising public health interventions that may extend healthy life expectancy at older age are vitamin D, marine omega-3 fatty acids and physical exercise. However, their individual and combined effects have yet to be confirmed in a clinical trial.
The broad aim of DO-HEALTH is to prolong healthy life expectancy in European seniors. The specific aim is to establish whether vitamin D, omega-3 fatty acids, and a simple home exercise program will prevent disease at older age.
To achieve these aims, DO-HEALTH will enroll 2152 community-dwelling men and women who are 70 years and older, an age when chronic diseases increase substantially. The DO-HEALTH seniors will be recruited from 7 European cities (Zurich, Basel, Geneva, Toulouse, Berlin, Innsbruck and Coimbra) and will be randomized in a 2x2x2 factorial design trial to a simple home exercise program and/or vitamin D, and/or omega-3 fatty acids, over a 3 year period. This will allow to test the individual and the combined benefit of the interventions in the prevention of 5 primary endpoints: incident non-vertebral fractures; functional decline; systolic and diastolic blood pressure change; cognitive decline; and the rate of any infection. Key secondary endpoints include incidence of hip fractures, rate of falls, severity of pain in symptomatic knee osteoarthritis, gastro-intestinal symptoms, mental and oral health, quality of life, and mortality.
All clinical endpoints will be supported by a large DO-HEALTH biomarker study to evaluate the effect of the interventions at the cellular level of multi-organ function. DO-HEALTH will further evaluate reasons why or why not seniors adhere to the 3 interventions, and will assess their cost-benefit in a health economic model based on documented health care utilization and observed incidence of chronic disease.
website DO-HEALTH: http://do-health.eu/wordpress/
- Detailed Description
The 3 primary treatment comparisons are:
1. 2000 IU vitamin D per day compared to placebo (controlling for the other treatment strategies)
2. 1 g of omega-3 fatty acids (EPA+DHA, ratio 1:2, from marine algae) compared to placebo (controlling for the other treatment strategies)
3. Home exercise program (muscle strength) of 30 minutes 3 times a week compared to a control exercise program (joint flexibility) 30 minutes 3 times a week
Follow-up: DO-HEALTH seniors will be followed for 3 years, in-person, and in 3-monthly intervals (4 clinical visits and 9 phone calls) at the 7 recruitment centers.
Study population: DO-HEALTH will enroll seniors age 70 years and older. To represent the largest part of the senior population, DO-HEALTH will recruit community-dwelling seniors. However, to represent also the pre-frail population at risk of institutionalization, at least 40% of seniors will be enrolled based on a fall with or without a fracture in the year before DO-HEALTH enrolment.
Study Design: This is a randomized, double-blind, placebo-controlled, 2×2×2 factorial design clinical trial.
Recruitment Centers: The trial will be performed at 7 recruitment centers located in 5 countries: Switzerland (University of Zurich, Basel University Hospital, Geneva University Hospital), France (University of Toulouse Hospital Centre), Germany (Charité Berlin), Portugal (University of Coimbra), and Austria (Innsbruck Medical University).
Randomization: Stratified block randomization. Labeling of study intervention will be performed by a central randomization centre in Switzerland.
Stratification variables: recruitment centre (7 centers), fall during previous 12 months (yes/no), gender, and age (70 - 84 and 85+). At least 40% of Seniors among those who fell or did not fall during the last year will be enforced at each of the 7 recruitment centers. Gender and age distribution will be monitored within each recruitment centre with the DO-HEALTH randomization software. If gross imbalance (less than 30% of fallers/non-fallers in a stratum) is detected within a centre, recruitment strategies for the centre will be adapted to boost recruitment of participants of underrepresented category.
website DO-HEALTH: http://do-health.eu/wordpress/
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2157
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description VitD-Omega3-StrengthExercise Strength Home Exercise Vitamin D3 (2000 IU/d); Omega-3 fatty acids (1 g/d); Strength Home Exercise (3\*30 minutes/week) Placebo-Placebo-StrengthExercise Strength Home Exercise Placebo Vitamin D3; Placebo Omega-3 fatty acids; Strength Home Exercise (3\*30 minutes/week) VitD-Omega3-FlexibilityExercise Flexibility Home Exercise Vitamin D3 (2000 IU/d); Omega-3 fatty acids (1 g/d); Flexibility Home Exercise (3\*30 minutes/week) Placebo-Omega3-StrengthExercise Strength Home Exercise Placebo Vitamin D3; Omega-3 fatty acids (1 g/d); Strength Home Exercise (3\*30 minutes/week) Placebo-Placebo-FlexibilityExercise Flexibility Home Exercise Placebo Vitamin D3; Placebo Omega-3 fatty acids; Flexibility Home Exercise (3\*30 minutes/week) VitD-Placebo-StrengthExercise Strength Home Exercise Vitamin D3 (2000 IU/d); Placebo Omega-3 fatty acids; Strength Home Exercise (3\*30 minutes/week) Placebo-Omega3-FlexibilityExercise Flexibility Home Exercise Placebo Vitamin D3; Omega-3 fatty acids (1 g/d); Flexibility Home Exercise (3\*30 minutes/week) VitD-Placebo-FlexiblityExercise Flexibility Home Exercise Vitamin D3 (2000 IU/d); Placebo Omega-3 fatty acids; Flexibility Home Exercise (3\*30 minutes/week) VitD-Omega3-StrengthExercise Vitamin D3 Vitamin D3 (2000 IU/d); Omega-3 fatty acids (1 g/d); Strength Home Exercise (3\*30 minutes/week) VitD-Omega3-FlexibilityExercise Vitamin D3 Vitamin D3 (2000 IU/d); Omega-3 fatty acids (1 g/d); Flexibility Home Exercise (3\*30 minutes/week) Placebo-Omega3-StrengthExercise Omega 3 fatty acids Placebo Vitamin D3; Omega-3 fatty acids (1 g/d); Strength Home Exercise (3\*30 minutes/week) Placebo-Omega3-FlexibilityExercise Omega 3 fatty acids Placebo Vitamin D3; Omega-3 fatty acids (1 g/d); Flexibility Home Exercise (3\*30 minutes/week) VitD-Placebo-StrengthExercise Vitamin D3 Vitamin D3 (2000 IU/d); Placebo Omega-3 fatty acids; Strength Home Exercise (3\*30 minutes/week) VitD-Placebo-FlexiblityExercise Vitamin D3 Vitamin D3 (2000 IU/d); Placebo Omega-3 fatty acids; Flexibility Home Exercise (3\*30 minutes/week) VitD-Omega3-StrengthExercise Omega 3 fatty acids Vitamin D3 (2000 IU/d); Omega-3 fatty acids (1 g/d); Strength Home Exercise (3\*30 minutes/week) VitD-Omega3-FlexibilityExercise Omega 3 fatty acids Vitamin D3 (2000 IU/d); Omega-3 fatty acids (1 g/d); Flexibility Home Exercise (3\*30 minutes/week)
- Primary Outcome Measures
Name Time Method Cardio-vascular: Systolic and diastolic blood pressure change Baseline, 12, 24 and 36 months Standardized blood pressure assessment in sitting position
Brain: Cognitive decline Baseline, 12, 24 and 36 months Montreal Cognitive Assessment (MoCA)
Bone: Incident non-vertebral fractures over 36 months over 36 months Confirmed by medical and/or x-ray reports
Muscle: Functional decline (lower extremity function) Baseline, 12, 24 and 36 months Measured with the SPPB (short physical performance test battery)
Immunity: Rate of any infections Baseline, and every 3 months up to 36 months 3-monthly incident infection protocol
- Secondary Outcome Measures
Name Time Method Cartilage/Bone: NSAID use / number of joints with pain Baseline, 12, 24, 36 months Assessed by questionnaire and homunculus figure
Global Health: Quality of life Every 6 months Assessed with questionnaire (EuroQuol).
Global Health: Incident nursing home admission 36 months Global Health: Mortality 36 months Bone: Incident total fractures 36 months Combined non-vertebral and vertebral fractures among subgroup of 1502 participants with DXA vertebral morphometry assessment
Bone: Incident hip fractures 36 months Based on medical records and/or x-ray reports
Muscle: reaction time and grip strength Baseline, 12,24,36 months Reaction time will be assessed with the repeated sit-to-stand test; grip strength will be assessed with the Martin Vigorimeter
Muscle: Muscle mass decrease at upper and lower extremities Baseline, 12,24,36 months Subset of 1502 participants with DXA measurements
Muscle/Bone: musculoskeletal pain Baseline, 12,24, and 36 months Assessed with the McGill questionnaire
Bone: Incident vertebral fractures 36 months Based on DXA vertebral morphometry among subset of 1502 participants
Muscle: Dual tasking 10-meter gait speed Baseline, 12,24 and 36 months Bone: Bone mineral density decrease at the lumbar spine and hip Baseline, 12, 24, and 36 months Assessed in a subset of 1502 participants with DXA measurements
Muscle: Rate of falls Assessed every 3 months over 36 months Any low trauma fall, injurious fall
Brain: mental health decline Baseline, 12,24, and 36 months Assessed with Geriatric Depression Scale
Brain/Muscle: Dual tasking gait variability Baseline, 12, 24 and 36 months Subset of 250 participants
Brain: Incident Depression 36 months Immunity: Incident severe infections that lead to hospital admission 36 months Cartilage/Bone: Severity of knee pain in participants with symptomatic knee osteoarthritis Baseline, 12, 24 and 36 months Assessed with the KOOS questionnaire. Knee OA assessment with modified ACR criteria.
Cardio-vascular: Incident Hypertension 36 months Immunity: Rate of upper respiratory infections / rate of flu-like illness 36 months Assessed with infection protocol every 3 months
Cartilage/Bone: Rate of knee buckling Baseline, 12,24,36 months Questionnaire-based.
Gastro-Intestinal: rate of GI symptoms Baseline, 12, 24 and 36 months Assessed with ROME III questionnaire.
Dental: Decline in oral health Baseline, 12,24 and 36 months Assessed with questionnaire.
Dental: Tooth loss 36 months Assessed by tooth count at every clinical visit
Glucose-Metabolic: Body composition Baseline, 12, 24, 36 months Subset of 1502 participants with DXA measurements
Kidney: Decline in kidney function Baseline, 12, 24, and 36 months Blood creatinine levels and estimated glomerular filtration rate
Glucose-Metabolic: Change in fasting glucose, insulin levels (QUICKI, HOMA index) Baseline, 12,24,36 months Laboratory measures at the Central DO-HEALTH Laboratory (Institute of Clinical Chemistry at the University Hospital Zurich)
Global Health: Incident disability regarding activities of daily living Baseline, 12, 24 and 36 months Assessed with HAQ-PROMIS questionnaire
Trial Locations
- Locations (7)
University of Toulouse - Centre de Recherche - Gérontopôle Hôpital La Grave
🇫🇷Toulouse, France
Charité Berlin
🇩🇪Berlin, Germany
University of Coimbra - Clínica Universitária de Reumatologia
🇵🇹Coimbra, Portugal
Centre on Aging and Mobility, University of Zurich and City Hospital Waid
🇨🇭Zurich, ZH, Switzerland
Hôpitaux Universitaires de Genève
🇨🇭Geneva, Switzerland
University of Innsbruck
🇦🇹Innsbruck, Austria
Basel University
🇨🇭Basel, Switzerland