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OpenTrials
Completed

NCT Number: NCT01421628

Enhancement of Physical Fitness in Older Adults

Ageing is related to a decrease in physical fitness, disability and age related symptoms like nocturnal leg cramps (NLC). Our research is focused on the enhancement of physical activity and mobility to increase physical fitness and decrease disability and nocturnal cramp in older adults.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kinese Fysiotherapeuten

Appingedam, Provincie Groningen, 9934 JD, Netherlands

About this study

The ageing population leads to an increase of chronic disease and disability and to a decrease of physical activity and ADL performance. This circle can be reversed by physical exercise to increase physical fitness.

The goal of this research is to establish the effects of a trainings program on ADL performance, physical fitness and nocturnal cramps. Furthermore the characteristics from participants who benefit from the program will be investigated by the research.

The study design is a randomized intervention study. Participants are elderly people, age 65 years and older, without cognitive impairment.

Intervention: The intervention is a physical trainings program. The intensity is moderate, the frequency is daily and the total duration is 6 weeks. The control group will be provided with an education program.

Main parameters are: physical fitness, nocturnal cramp severity and frequency.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For patients to be included in our study, they had to experience regular episodes of NLC and are in good mental health.
  • The participants had to agree to the study protocol and complete the program.
  • After eligibility was verified, written informed consent was obtained.

Exclusion criteria

  • Older adults taking quinine or sleep medication and those with orthopedic problems or with severe medical problems and co morbidity, which can cause muscular spasms and/or cramps.

Treatment and study plan

Fitness exercise program

Other

Exercise program, daily frequency, duration of 6 weeks.

Primary outcomes

  1. Physical fitness

    Time frame: six weeks

    Strength, balance

  2. ADL performance

    Time frame: six weeks

    Performance based ADL test

  3. Well being

    Time frame: six weeks

    Questionnaires like SF-36

  4. Nocturnal cramps

    Time frame: Six weeks

    Visual analogue scale (VAS)

Secondary outcomes

  1. Frequency nocturnal cramp

    Time frame: Six weeks

    Number of cramp attacks per day.

Sponsors and collaborators

Lead sponsor

Hanze University of Applied Sciences Groningen

Other

Collaborators

  • University Medical Center Groningen

Registry information

Official study title

The Effectiveness of a Trainings Program on ADL Performance, Physical Fitness, Wellbeing, and Nocturnal Cramp in Elderly People

Acronym: NLC2010

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 23, 2011
Registry last updated
Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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