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Completed

NCT Number: NCT07817914

Feasibility of an Interval Running Exercise Program With Self-Regulated Unloading 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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wielospecjalistyczny Szpital Samodzielny Publiczny Zakład Opieki Zdrowotnej w Nowej Soli

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Running Interval Training

Behavioral

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

Other names: Interval Running Exercise Program

Primary outcomes

  1. Feasibility of the Exercise Program (proportion (%) of participants meeting the described feasibility criteria across 4 domains: adherence, retention, tolerability, and safety)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University in Zielona Góra

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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