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Enhancement of Physical Fitness in Older Adults (NLC2010)

This study has been completed.
Sponsor:
Collaborator:
University Medical Centre Groningen
Information provided by:
Hanze University
ClinicalTrials.gov Identifier:
NCT01421628
First received: August 19, 2011
Last updated: August 22, 2011
Last verified: December 2010
  Purpose

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 Intervention
Pain
Physical Impairment
Other: Fitness exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effectiveness of a Trainings Program on ADL Performance, Physical Fitness, Wellbeing, and Nocturnal Cramp in Elderly People

Resource links provided by NLM:


Further study details as provided by Hanze University:

Primary Outcome Measures:
  • Physical fitness [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    Strength, balance

  • ADL performance [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    Performance based ADL test

  • Well being [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    Questionnaires like SF-36

  • Nocturnal cramps [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    Visual analogue scale (VAS)


Secondary Outcome Measures:
  • Frequency nocturnal cramp [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    Number of cramp attacks per day.


Enrollment: 180
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise Other: Fitness exercise program
Exercise program, daily frequency, duration of 6 weeks.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421628

Locations
Netherlands
Kinese Fysiotherapeuten
Appingedam, Groningen, Netherlands, 9934 JD
Sponsors and Collaborators
Hanze University
University Medical Centre Groningen
Investigators
Principal Investigator: Hank Hallegraeff, PT, MSc
  More Information

No publications provided

Responsible Party: Hank Hallegraeff Msc,PT, PhD student
ClinicalTrials.gov Identifier: NCT01421628     History of Changes
Other Study ID Numbers: HanzeUnlc
Study First Received: August 19, 2011
Last Updated: August 22, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Hanze University:
older adults
exercise
stretching
mobility

ClinicalTrials.gov processed this record on November 25, 2014