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Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study

9. oktober 2018 oppdatert av: Dr Evan Campbell, University of Glasgow

After the age of 40-45 years muscle mass and function progressively decline, reducing older peoples' abilities to perform tasks of daily living and also increase the risk of falls. It is known that, across the life course, resistance exercise can be of benefit in increasing muscle mass and function, yet how hard the exercise should be performed has received little attention. Current recommendations are for older people to perform exercise at 70% of the maximum they can lift, quite a high intensity that often puts older people off participating. Recent evidence in younger people has suggested that such intensities are not required.

The investigators aim to determine the feasibility of a study to investigate recruitment and adherence of older people to a study of exercise training at different intensities.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The cohort will comprise two sets of participants: frail older adults and non-frail older adults.

Each participant will receive 8 weeks of twice weekly supervised resistance training. Both the frail and non-frail participants will be randomised into either receiving high load resistance training or low load resistance training. High load resistance training will be delivered at 70% of the participants maximal capacity and low load resistance training will be delivered at 30% of maximal capacity. All resistance training will focus on the lower limb and regardless of intensity each exercise will be done to failure (unable to complete another full repetition).

Studietype

Intervensjonell

Registrering (Forventet)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Non-frail - Over 65 years of age Frail - Over 65 years of age, Three or more of the following criteria: >10lbs of weight loss unintentionally in previous year; grip strength in lowest 20% (by sex and BMI); self-reported exhaustion; walking time for 15 feet in slowest 20% (by sex and height); physical activity in the lowest 20%.

Exclusion Criteria:

Non-frail - Current participation in an exercise programme. Clinical team do not think resistance exercise would be safe or unable to consent. Any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in Geriatric Medicine where required.

Frail - Current participation in an exercise programme. Clinical team do not think resistance exercise would be safe or unable to consent. Any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in Geriatric Medicine where required.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: High load non-frail
Non-frail participants who will receive resistance training at 70% of their maximal strength
Annen: resistance training
Moving muscles against loads with the purpose of increasing strength.
Aktiv komparator: low load non-frail
Non-frail participants who will receive resistance training at 30% of their maximal strength
Annen: resistance training
Moving muscles against loads with the purpose of increasing strength.
Eksperimentell: high load frail
Frail participants who will receive resistance training at 70% of their maximal strength
Annen: resistance training
Moving muscles against loads with the purpose of increasing strength.
Eksperimentell: low load frail
Frail participants who will receive resistance training at 30% of their maximal strength
Annen: resistance training
Moving muscles against loads with the purpose of increasing strength.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of training sessions attended
Tidsramme: 8 weeks
Expressed as a percentage of number of sessions attended
8 weeks
Compliance with protocol
Tidsramme: 8 weeks
Expressed as a percentage of number of sessions where training protocol was adhered to
8 weeks
Number of treatment-related adverse events as assessed by CTCAE v4.0
Tidsramme: 8 weeks
Number of adverse events that could be attributed to the intervention
8 weeks
Acceptability of intervention (qualitative)
Tidsramme: 8 weeks
focus groups with semi-structured discussion plans will investigate the acceptability of the intervention
8 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Muscle thickness
Tidsramme: 8 weeks
Thickness of vastus lateralus using ultrasound (mm)
8 weeks
Muscle power
Tidsramme: 8 weeks
Maximum voluntary contraction of a muscle at a set angle to produce a torque (kg)
8 weeks
Muscle strength
Tidsramme: 8 weeks
Maximal load participant can lift (kg)
8 weeks
Frailty
Tidsramme: 8 weeks
As measured by the Fried criteria. These are low energy expenditure, slow gait speed, weak grip strength, exhaustion, and unintentional weight loss. Fulfilling three of these criteria indicates clinical frailty.
8 weeks
Quality of life
Tidsramme: 8 weeks
Measured using the Euroqol EQ-5 Dimension- 5 Level self report measure. This scale measures quality of life in 5 dimensions and produces an index of quality of life rangin from a worst quality of life at -1 to best quality of life at 1.
8 weeks
Activities of daily living
Tidsramme: 8 weeks
Measured using the Barthel index. This scale measures ten variables of activities of daily living and produces an overall score. This ranges from 0-20 with a higher score indicating greater independence.
8 weeks
Activities of daily living
Tidsramme: 8 weeks
Measured using the Lawton ADL scale. this self report measures assess independence in daily living in 8 different domains but produces an overall score. Scores range from 0-8 with 8 indicating full independence.
8 weeks
Functional abilities
Tidsramme: 8 weeks
Short performance battery test. This battery of tests assesses balance, gait speed and lower limb strength. Scores are awarded for each individual section and aggregated ranging from 0-12 with a higher score indicating greater physical capability.
8 weeks
motion analysis
Tidsramme: 8 weeks
biomechanical assessment using infr-red motion analysis cameras
8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Glasgow

Samarbeidspartnere

NHS Greater Glasgow and Clyde

Etterforskere

  • Hovedetterforsker: Evan Campbell, PhD, Univeristy of Glasgow

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. august 2018

Primær fullføring (Forventet)

29. november 2019

Studiet fullført (Forventet)

29. november 2019

Datoer for studieregistrering

Først innsendt

2. august 2018

Først innsendt som oppfylte QC-kriteriene

8. august 2018

Først lagt ut (Faktiske)

13. august 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. oktober 2018

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 3.0

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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