Vitamin D and Resistance Exercise in Elderly (NUTRIAGINGVitD)

NCT04341818 | Unknown

• 1 other identifier: FA219002_2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Keywords

aging; vitamin D; resistance training

Outcome Measures

Primary Outcomes (1)

• Change from baseline in handgrip strength (kg)

  Handgrip strength of the right hand will be measured to the nearest kilogram (kg) using a hand Dynamometer. Participants will be encouraged to perform a maximal contraction within approximately 4 to 5 s. After a rest of 60 s, participants will be asked to perform a second trial. The highest score of maximum voluntary contraction will be used for data analyses.

  baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)

Secondary Outcomes (12)

• Change from baseline in chair stand test (repetitions within 30s)

  baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)

• Change from baseline in muscle mass with BIA (kg)

  baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)

• Change from baseline in 6min walking test (distance in meter)

  baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)

• Change from baseline in the composition of gut-microbiota

  baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)

• Change from baseline in stool short-chain fatty acids (SCFAs)

  baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)

Study Arms (3)

Strength Training and Vitamin D monthly

EXPERIMENTAL

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.

Other: Strength Training and Vitamin D monthly

Strength Training and Vitamin D daily

EXPERIMENTAL

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.

Other: Strength Training and Vitamin D daily

Strength Training and no Vitamin D

EXPERIMENTAL

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.

Other: Strength Training and no Vitamin D

Interventions

Strength Training and Vitamin D monthly OTHER

For 4 wks 50.000 IU vitamin D is given as a monthly dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks 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 and calcium intake remain.

Strength Training and Vitamin D monthly

Strength Training and Vitamin D daily OTHER

For 4 wks 800 IU vitamin D is given as a daily dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks 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 and calcium intake remain.

Strength Training and Vitamin D daily

Strength Training and no Vitamin D OTHER

For 4 wks no vitamin D is administered, followed by a 10 weeks 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 also no vitamin D is given. Over the whole study period participants get 400 mg calcium/day.

Strength Training and no Vitamin D

Eligibility Criteria

• Age: 65 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Vitamin D plasma level of 75 nmol/l or above

Sponsors & Collaborators

• University of Vienna: lead

Study Sites (1)

University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Human Nutrition

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: January 15, 2019
• Primary Completion: August 20, 2019
• Study Completion: December 1, 2021
• Last Updated: April 13, 2020

Record last verified: 2020-04

Locations

AU (1)