- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Groningen
-
Appingedam, Groningen, Holland, 9934 JD
- Kinese Fysiotherapeuten
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: dyrke motion
|
Exercise program, daily frequency, duration of 6 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical fitness
Tidsramme: six weeks
|
Strength, balance
|
six weeks
|
|
ADL performance
Tidsramme: six weeks
|
Performance based ADL test
|
six weeks
|
|
Well being
Tidsramme: six weeks
|
Questionnaires like SF-36
|
six weeks
|
|
Nocturnal cramps
Tidsramme: Six weeks
|
Visual analogue scale (VAS)
|
Six weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency nocturnal cramp
Tidsramme: Six weeks
|
Number of cramp attacks per day.
|
Six weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Hank Hallegraeff, PT, MSc
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- HanzeUnlc
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