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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Physical Impairment Other: Fitness exercise program Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effectiveness of a Trainings Program on ADL Performance, Physical Fitness, Wellbeing, and Nocturnal Cramp in Elderly People
Study Start Date : September 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: exercise Other: Fitness exercise program
Exercise program, daily frequency, duration of 6 weeks.

Primary Outcome Measures :
  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 Outcome Measures :
  1. Frequency nocturnal cramp [ Time Frame: Six weeks ]
    Number of cramp attacks per day.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421628

Kinese Fysiotherapeuten
Appingedam, Groningen, Netherlands, 9934 JD
Sponsors and Collaborators
Hanze University
University Medical Center Groningen
Principal Investigator: Hank Hallegraeff, PT, MSc

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hank Hallegraeff Msc,PT, PhD student Identifier: NCT01421628     History of Changes
Other Study ID Numbers: HanzeUnlc
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: December 2010

Keywords provided by Hanze University:
older adults