Enhancement of Physical Fitness in Older Adults (NLC2010)

August 22, 2011 updated by: Hanze University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Groningen
      • Appingedam, Groningen, Netherlands, 9934 JD
        • Kinese Fysiotherapeuten

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical fitness
Time Frame: six weeks
Strength, balance
six weeks
ADL performance
Time Frame: six weeks
Performance based ADL test
six weeks
Well being
Time Frame: six weeks
Questionnaires like SF-36
six weeks
Nocturnal cramps
Time Frame: Six weeks
Visual analogue scale (VAS)
Six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency nocturnal cramp
Time Frame: Six weeks
Number of cramp attacks per day.
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanze University

Collaborators

University Medical Center Groningen

Investigators

  • Principal Investigator: Hank Hallegraeff, PT, MSc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 22, 2011

First Posted (Estimate)

August 23, 2011

Study Record Updates

Last Update Posted (Estimate)

August 23, 2011

Last Update Submitted That Met QC Criteria

August 22, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HanzeUnlc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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