Enhancement of Physical Fitness in Older Adults (NLC2010)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421628
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : August 23, 2011
University Medical Center Groningen
Information provided by:
Hanze University

August 19, 2011
August 23, 2011
August 23, 2011
September 2010
November 2010   (Final data collection date for primary outcome measure)
  • Physical fitness [ Time Frame: six weeks ]
    Strength, balance
  • ADL performance [ Time Frame: six weeks ]
    Performance based ADL test
  • Well being [ Time Frame: six weeks ]
    Questionnaires like SF-36
  • Nocturnal cramps [ Time Frame: Six weeks ]
    Visual analogue scale (VAS)
Same as current
No Changes Posted
Frequency nocturnal cramp [ Time Frame: Six weeks ]
Number of cramp attacks per day.
Same as current
Not Provided
Not Provided
Enhancement of Physical Fitness in Older Adults
The Effectiveness of a Trainings Program on ADL Performance, Physical Fitness, Wellbeing, and Nocturnal Cramp in Elderly People
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Pain
  • Physical Impairment
Other: Fitness exercise program
Exercise program, daily frequency, duration of 6 weeks.
Experimental: exercise
Intervention: Other: Fitness exercise program
Hallegraeff JM, van der Schans CP, de Ruiter R, de Greef MH. Stretching before sleep reduces the frequency and severity of nocturnal leg cramps in older adults: a randomised trial. J Physiother. 2012;58(1):17-22. doi: 10.1016/S1836-9553(12)70068-1.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2010
November 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
65 Years and older   (Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Hank Hallegraeff Msc,PT, PhD student
Hanze University
University Medical Center Groningen
Principal Investigator: Hank Hallegraeff, PT, MSc
Hanze University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP