Feasibility of an Interval Running Exercise Program With Self-Regulated Unloading in Adults Aged 60 and Older
9. september 2026 oppdatert av: Franciszek Pietraszkiewicz, University in Zielona Góra
Feasibility and Preliminary Effects of an Exercise Model Based on Running Interval Training With Self-Regulated Unloading on Body Composition, Physical Fitness and Exercise Capacity, Muscle Strength, Pain Level, and Fall Risk in Adults Aged 60 and Older
This pilot study will evaluate whether a short, self-regulated interval exercise program is practical and safe for adults aged 60 and older.
The program consists of short periods of running or walking in place, with rest periods between exercises, and allows participants to adjust the intensity to their individual abilities.
The findings will help determine whether this type of exercise program is suitable for further research in larger studies.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Regular physical activity is important for maintaining health and physical function in older adults. However, conventional exercise programs may be difficult to perform because of limited mobility, joint pain, concerns about injury, or other individual barriers. Short bouts of exercise combined with individually regulated joint unloading may provide a practical and adaptable approach for older adults. This pilot feasibility study will evaluate a novel self-regulated interval exercise program designed for adults aged 60 to 80 years. The program is inspired by the concepts of high-intensity interval training (HIIT) and exercise snacks, but is adapted to the individual physical abilities of older adults.
The intervention will last 4 weeks. Assessments will include adherence and adverse events monitoring, body composition analysis by a bioelectrical impedance method, lower-extremity muscle strength assessment using the five times sit to stand test (FTSST), aerobic capacity assessment by 2-minute step in place test (2MST), pain intensity assessment using numerical rating scale (NRS), and fall risk assessment using timed up & go test (TUG).
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Lubusz Voivodeship
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Nowa Sól, Lubusz Voivodeship, Polen, 67-100
- Wielospecjalistyczny Szpital Samodzielny Publiczny Zakład Opieki Zdrowotnej w Nowej Soli
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-
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- age between 60-80 years
- written consent to participate in the study
Exclusion Criteria:
- unstable angina
- circulatory and respiratory failure
- implanted metal materials (e.g. defibrillator, pacemaker, stent)
- a mental disorder that makes it difficult to cooperate with medical personnel
- inability to safely perform exercise at an exertion corresponding to rating of perceived exertion (RPE) ≥ 14 on the 6-20 Borg scale
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Running Interval Training
|
The intervention will last 4 weeks.
Participants will perform four exercise sessions each day.
Each session will consist of five 1-minute periods of running or walking in place, separated by 20-second rest periods.
Gymnastic sticks will be used to allow participants to regulate the amount of weight placed through the lower extremities.
Participants will be able to increase or decrease the amount of support provided by the sticks according to their individual needs and comfort, thereby self-regulating the unloading of the lower-extremity joints.
The target exercise intensity corresponds to rating of perceived exertion (RPE) ≥ 14 on the 6-20 Borg scale
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of the Exercise Program (proportion (%) of participants meeting the described feasibility criteria across 4 domains: adherence, retention, tolerability, and safety)
Tidsramme: From baseline through post-intervention assessment following the 4-week intervention period
|
Feasibility will be assessed as the proportion (%) of participants meeting the following feasibility criteria across 4 domains: adherence, retention, tolerability, and safety.
Adherence: % of participants completing ≥75% of prescribed training days (weekly training recordings).
Green ≥75%, amber 50-74%, red <50%.
Retention: % completing intervention and post-assessment.
Green ≥80%, amber 60-79%, red <60%.
Tolerability: % with worsening in strength (Five Times Sit-to-Stand Test), aerobic capacity (2-Minute Step Test), or pain (Numeric Rating Scale).
Green ≤20%, amber 20-30%, red >30%.
Safety: % reporting minor adverse events and number of serious adverse events (SAE) (medical records).
Green <10% and no related SAE; amber 10-40% and no related SAE; red >40% or any related SAE.
Overall feasibility: all domains green = feasible without modification; any amber with no red = feasible after modification; any red = not feasible and requires major modification and further feasibility testing.
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From baseline through post-intervention assessment following the 4-week intervention period
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Franciszek Pietraszkiewicz, University of Zielona Góra
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)
11. oktober 2024
Primær fullføring (Faktiske)
1. mars 2025
Studiet fullført (Faktiske)
1. mars 2025
Datoer for studieregistrering
Først innsendt
26. august 2026
Først innsendt som oppfylte QC-kriteriene
9. september 2026
Først lagt ut (Faktiske)
14. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- UZ/0015.37/2024
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Participants provided consent for their data to be accessed by members of the research team to the extent necessary to conduct the study.
Individual participant data will not be shared with researchers or other entities outside the research team.
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. .