Old AgeNCT07817914
Feasibility of an Interval Running Exercise Program With Self-Regulated Unloading in Adults Aged 60 and Older
A study testing Running Interval Training in people with Old Age and Aged 60 Years or Older, run by University in Zielona Góra at 1 site in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Old Age, Aged 60 Years or Older, Aged
- What is being tested?
- Running Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 11 Oct 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 60-80 years
- written consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Wielospecjalistyczny Szpital Samodzielny Publiczny Zakład Opieki Zdrowotnej w Nowej Soli
Nowa Sól, Lubusz Voivodeship, 67-100
About this study
Official 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
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.
Read the detailed description
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).
- Conditions
- Old Age, Aged 60 Years or Older, Aged
- Being tested
- Running Interval Training
- Keywords
- Exercise Therapy, High-Intensity Interval Training, Feasibility Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Running Interval TrainingBehavioural
Also called Interval Running Exercise Program
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
| Study group | Role | What they receive |
|---|---|---|
| Running Interval Training | Experimental | Not described Receives: Behavioral: Running Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Exercise Program (proportion (%) of participants meeting the described feasibility criteria across 4 domains: adherence, retention, tolerability, and safety)
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.
Measured: From baseline through post-intervention assessment following the 4-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start11 Oct 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University in Zielona Góra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franciszek Pietraszkiewicz, University in Zielona Góra
- Investigators
- Franciszek Pietraszkiewicz, Principal investigator, University of Zielona Góra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817914
- Sponsor's protocol ID
- UZ/0015.37/2024
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07817914
- Acronym / sponsor ID
- UZ/0015.37/2024
- Conditions
- Old Age, Aged 60 Years or Older, Aged
- Keywords
- Exercise Therapy, High-Intensity Interval Training, Feasibility Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University in Zielona GóraUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Running Interval Training | Experimental | Behavioral: Running Interval Training |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 60-80 years
- written consent to participate in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Running Interval TrainingAlso: Interval Running Exercise ProgramThe 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 | Behavioural | Running Interval Training |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franciszek Pietraszkiewicz principal investigator
University of Zielona Góra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Running Interval Training in people with Old Age and Aged 60 Years or Older, run by University in Zielona Góra at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.