Trial document




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  DRKS00003622

Trial Description

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Title

Health Risks of Indoor Cold Environment

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Trial Acronym

ICE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It is well known that the next decade will bring an exponential increase in very old persons. A considerable number of these will have limited economic resources. The global energy demand will drastically increase the cost of heating and thereby threaten housing health conditions. This is particularly problematic in older persons suffering from muscular problems, which is very prevalent in older women. The muscles are the main source of internal heating. This might lead to a vicious circle influencing mobility patterns and increasing the incidence of falls. Falling is one of the leading causes of death and nursing home admission in older people. The effect of cold room temperature on motor performance of older women with and without muscular problems will be tested in a unique mobility laboratory equipped as a climate chamber. The power of functional performance and its association with muscle mass will be investigated. Walking performance with and without an additional cognitive task as well as physical activity assessed through body-worn activity monitors will help to understand this issue. The hypothesis that the physical performance of older women is worse during exposure to a cold environment (15°C) compared to a warm environment (25°C), and this is more evident in persons with less muscle mass will be investigated. The results of this study may influence future strategies for optimizing the muscular status of older women.

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Brief Summary in Scientific Language

It is well known that the next decade will bring an exponential increase in very old persons. A considerable number of these will have limited economic resources. The global energy demand will drastically increase the cost of heating and thereby threaten housing health conditions. This is particularly problematic in older persons suffering from sarcopenia which is very prevalent in older women. Muscle tissue has the key role in the intrinsic temperature control and is the main source of internal thermogenesis. This might lead to a vicious circle influencing mobility patterns and increasing the incidence of falls. Falling is one of the leading causes of death and institutionalization in older people. The effect of cold room temperature on motor performance of older women with and without sarcopenia will be tested in a unique mobility laboratory equipped as a climate chamber. The power of functional performance and its association with muscle mass will be the main outcome of the study. Gait analysis parameters including dual-task costs as well as physical activity assessed through body-worn activity monitors will serve as explanatory variables. It is hypothesized that the physical performance of older women is worse during exposure to a cold environment (15°C) compared to a warm environment (25°C), and that this is more evident in persons with less muscle mass. The results of this study may influence future strategies for optimizing the muscular status of older women.

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Organizational Data

  •   DRKS00003622
  •   2012/03/15
  •   [---]*
  •   yes
  •   Approved
  •   578/2011BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   healthy older women
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Interventions/Observational Groups

  •   Assessment of physical performance (power, gait analysis, sit-to-stand transfer, grip strength, leg extension strength, balance) exposed to 15°C and 25°C in randomized order. Assessment of quality of life, cognition, depression, nutritional status, and thermal well-being by questionnaires. Assessment of physical activity by body-worn sensors and questionnaire. Assessment of muscle mass (thigh) by MRI. Blood samples (inflammatory markers) are taken at normal room temperature.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoint is muscle power assessed by the Nottingham Power Rig at 15°C and 25°C and the correlation between the change of power, related to different environmental temperature, and muscle mass assessed by MRI.

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Secondary Outcome

Secondary endpoint are cognition, assessed by the Trail Making Test, walking performance in single-task and dual-task condition (counting backwards in steps of 3), assessed on a GAITRite mat,and the sit-to-stand performance, classified by the time needed, during exposure to 15°C and 25°C environment, each.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/09/18
  •   96
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   70   Years
  •   101   Years
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Additional Inclusion Criteria

self-reported weakness of the legs

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Exclusion Criteria

(1) cognitive impairment indicating a possible dementia, (2) the presence of uncontrolled cardiac illness, (3) functional relevant disease (e.g. neurological and/or orthopedic), which significantly influences walking performance or leg extension, and (4) terminal illness

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Robert-Bosch-Krankenhaus
    • Mr.  PD Dr.  Clemens  Becker 
    • Auerbachstr. 110
    • 70376  Stuttgart
    • Germany
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    • Robert-Bosch-Krankenhaus
    • Mr.  Dr.  Ulrich  Lindemann 
    • Auerbachstr. 110
    • 70376  Stuttgart
    • Germany
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    • Robert-Bosch-Krankenhaus
    • Mr.  Dr.  Ulrich  Lindemann 
    • Auerbachstr. 110
    • 70376  Stuttgart
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/31
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Trial Publications, Results and other Documents

  •   Lindemann U, Oksa J, Skelton DA, Beyer N, Klenk J, Zscheile J, Becker C. Effect of cold indoor environment on physical performance of older women living in the community. Age and Ageing 2014; 43: 571-575
  •   Lindemann U, Farahmand P, Klenk J, Blatzonis K, Becker C. Validity of linear encoder measurement of sit-to-stand performance power in older people. Physiotherapy 2015; 101: 298-302
  •   Lindemann U, Mohr C, Machann J, Blatzonis K, Rapp K, Becker C. Association between Thigh Muscle Volume and Leg Muscle Power in Older Women. PLoS One. 2016 Jun 17;11(6):e0157885
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* This entry means the parameter is not applicable or has not been set.