- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01421628
Enhancement of Physical Fitness in Older Adults (NLC2010)
The Effectiveness of a Trainings Program on ADL Performance, Physical Fitness, Wellbeing, and Nocturnal Cramp in Elderly People
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Groningen
-
Appingedam, Groningen, Netherlands, 9934 JD
- Kinese Fysiotherapeuten
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Hank Hallegraeff, PT, MSc
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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