Vitamin D and Resistance Exercise in Elderly (NUTRIAGINGVitD)

University of Vienna

Status: Unknown

Conditions: Aging

Treatments: Other: Strength Training and Vitamin D daily; Other: Strength Training and no Vitamin D; Other: Strength Training and Vitamin D monthly

Study type: Interventional

Funder types: Other

Identifiers

NCT04341818

FA219002_2

Details and patient eligibility

About

The aim of this randomized, double-blind, controlled intervention study with parallel groups is to investigate the effect of resistance training (2x/week for 10 weeks) with and without different goals of vitamin D intake on muscle strength, function and mass, oxidative stress parameters and the immune system in community dwelling persons. Participants (n = 100) will be community-dwelling older adults. After a preparticipation screening and a vitamin D blood investigation (vitamin D status below 75 nmol/L) participants will be distributed randomly but stratified by sex, age and initial vitamin D plasma levels to one of the 3 groups (Vitamin D daily + strength training, Vitamin D monthly + strength training, no Vitamin D + strength training).

Study participants are eligible if they are male or female with an age between 65 and 85 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the training sessions, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, a frailty index at or above 3, medication with anticoagulants or cortisone drugs, a regular strength training during the last six months and a vitamin D plasma concentration of 75nmol/L or above.

Primary outcome measure is the change in the handgrip strength. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters, DNA/Chromosomal damage microbiota, metabolomics and the nutritional status.

Enrollment: 100 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females between the age of 65 and 85 years
• Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State >23)
• Independently mobile

Exclusion criteria

• Chronic diseases, which contraindicate a training participation
• Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
• Diabetic retinopathy
• Manifest osteoporosis
• Regular use of cortisone-containing drugs
• Regular strength training (> 1x / week) in the last 6 months before inclusion
• Vitamin D plasma level of 75 nmol/l or above

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups

Strength Training and Vitamin D monthly

Experimental group

Description:

Four weeks of Vitamin D (50.000 IU once per month) followed by a 10 week guided resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D intake remains. Over the whole study period participants get 400 mg calcium/day.

Treatment:

Other: Strength Training and Vitamin D monthly

Strength Training and Vitamin D daily

Experimental group

Description:

Four weeks of Vitamin D (800 IU once per day) followed by a 10 week guided resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D intake remains. Over the whole study period participants get 400 mg calcium/day.

Treatment:

Other: Strength Training and Vitamin D daily

Strength Training and no Vitamin D

Experimental group

Description:

Four weeks of no vitamin D administration followed by a 10 week guided resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D intake remains. Over the whole study period participants get 400 mg calcium/day.

Treatment:

Other: Strength Training and no Vitamin D