Enhancement of Physical Fitness in Older Adults (NLC2010)
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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 |
- 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)
- 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 |
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| Netherlands | |
| Kinese Fysiotherapeuten | |
| Appingedam, Groningen, Netherlands, 9934 JD | |
| 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 May 19, 2013