Trial document




drksid header

  DRKS00009331

Trial Description

start of 1:1-Block title

Title

Optimizing currant exercise strategies of public compulsory health insurances for musculoskeletal prevention. A randomized controlled pilot study with postmenopausal women

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

OPS

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Due to the menopausal transition bone and muscle in women are negatively affected in a relatively early phase of live, which may result in pain, decreases in functional capacity and loss of independence with advancing age. Regular exercise improves musculoskeletal parameters and is thus considered as an important component of osteoporosis and sarcopenia prevention or treatment. Actually, the corresponding exercise programs of compulsory health insurances (CHI) focus on intermitted programs over 10-12 weeks, with a single session/week and at most applied twice per year. This proceeding, however, is in conflict with the current finding that training frequencies lower than two sessions per week are ineffective or suboptimal to address musculoskeletal parameters (i.e. bone and muscle) in untrained middle- and high-aged females. Thus, the aim of this randomized, controlled pilot exercise trial was to determine whether (1) the present exercise strategy of the CHIs are generally effective to generate positive effects on osteoporosis and sarcopenia parameters and whether (2) adjuvant time- and cost-efficient modern training methods (i.e. video guided home exercise, whole-body vibration) may enhance the effectivity of low-frequency exercise programs.
Apart from the scientific evaluation of the project, we further aimed for increasing the applicability and attractiveness of whole-body vibration technology and home- or job-based video-animated exercise programs.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Due to the menopausal transition bone and muscle in women are negatively affected in a relatively early phase of live, which may result in pain, decreases in functional capacity and loss of independence with advancing age. Regular exercise improves musculoskeletal parameters and is thus considered as an important component of osteoporosis and sarcopenia prevention or treatment. Actually, the corresponding exercise programs of compulsory health insurances (CHI) focus on intermitted programs over 10-12 weeks, with a single session/week and at most applied twice per year. This proceeding, however, is in conflict with the current finding that training frequencies lower than two sessions per week are ineffective or suboptimal to address musculoskeletal parameters (i.e. bone and muscle) in untrained middle- and high-aged females. Thus, the aim of this randomized, controlled pilot exercise trial was to determine whether (1) the present exercise strategy of the CHIs are generally effective to generate positive effects on osteoporosis and sarcopenia parameters and whether (2) adjuvant time- and cost-efficient modern training methods (i.e. video guided home exercise, whole-body vibration) may enhance the effectivity of low-frequency exercise programs.
Apart from the scientific evaluation of the project, we further aimed for increasing the applicability and attractiveness of whole-body vibration technology and home- or job-based video-animated exercise programs.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009331
  •   2015/09/07
  •   [---]*
  •   yes
  •   Approved
  •   100_15 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M81 -  Osteoporosis without pathological fracture
  •   M62.5 -  Muscle wasting and atrophy, not elsewhere classified
  •   pain intensity and volume at different regions
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Usual Care prevention protocol according to § 20 SGB IX: Two periods of 10 weeks of supervised conventional group exercise once a week for 60 min. (i.e. predominately resistance-type) with intermittent 10 weeks of rest over 12 months.
    CA-/Vit-D-supplementation according to dietary intake.
  •   See study arm 1 + DVD-video-exercise.
    Additionally to the group sessions, participants performed one home training session of 30 min/week Subjects were guided by a video. During the intermittent rest periods (10 weeks) subjects performed 3 corresponding sessions per week.
    Intervention: 12 months
    CA-/Vit-D-supplementation according to dietary intake.
  •   See study arm 2 + whole body vibration (WBV). During the supervised phases of 10 weeks the exercise protocol was comparable to study arm 2; however during the intermittent rest periods, 2 home-trainings sessions (video-guided, see study arm 2) and 2 WBV-sessions with 15 min were performed.
    Intervention 12 months.
    CA-/Vit-D-supplementation according to dietary intake.
  •   Non-training control, that maintained there life-style during the intervention period of 12 months.
    However, participants were provided with calcium/Vitamin D (all groups) and theory sessions of healthy aging.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, caregiver, data analyst
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Bone Mineral Density (BMD) at lumbar spine (LS) and hip;
Appendicular skeletal muscle mass (ASMM);

BMD at LS and hip via regional DXA-scan at baseline and after 12 months;
ASMM via DXA-total body scan at baseline, after 6 and 12 months;

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Total and regional fat and fat free mass (DXA);
cross sectional area and density of the medial thigh (computed tomography: CT);
maximum strength (isokinetic assessment); functional capacity (e.g. balance tests, gait speed);
endurance (time under load, VO2max);
pain intensity and frequency at different skeletal sites (lower back, big joints via standardized questionnaire).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2020/01/01
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

female, postmenopausal
osteopenia (-1> T-Score<-2,5 SD) at lumbar spine or hip
untrained (</=1 session/week of exercise)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

relevant cardiovascular diseases
used medication and/or suffered from diseases affecting our primary end-points
absence for more than 2 weeks during the intervention period
(very) low physical capacity (≤75 Watt bicycle ergometry)
ineligibility for group exercise
contraindications for whole body vibration according to the supplier

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Erlangen
    • Maximiliansplatz 2
    • 91054  Erlangen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Friedrich Alexander Universität Erlangen-Nürnberg; Institut für Medizinische Physik,
    • Mr.  Professor Dr.  Wolfgang  Kemmler 
    • Henkestrasse 91
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Friedrich Alexander Universität Erlangen-Nürnberg, Institut für Medizinische Physik,
    • Mr.  Professor Dr.  Wolfgang  Kemmler 
    • Henkestrasse 91
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Friedrich Alexander Universität Erlangen-Nürnberg, Institut für Medizinische Physik,
    • Mr.  Professor Dr.  Wolfgang  Kemmler 
    • Henkestrasse 91
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.