Healthy AgingONTRAELNCT05885165
Supervised Online Resistance Training vs Unsupervised Self-administered Resistance Training for Elders
A study testing Supervised team-based exercise and Unsupervised exercise in people with Healthy Aging, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The primary goal of this project is to investigate whether online supervised team-based exercise training is superior for increasing functional strength in elders compared to prescribed self-administered exercise training. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Supervised team-based exercise and Unsupervised exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2023to 15 Nov 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 65 years.
- Danish reading and listening proficiency.
- Participant is in possession of either a computer, tablet, or smartphone in order to participate in Zoom meetings (supervised team-based group) or training programs via Exorlive (unsupervised group).
- The participant is able to walk independently and without external aids.
Who cannot join
- BMI > 35 kg/m2.
- Participation in other intervention studies or intention to do so, which are likely to affect the present study.
- Known diseases which may affect energy expenditure and/or satiation/satiety/food intake i.e. inflammatory bowel disease, thyroid diseases.
- Current diagnosis of eating disorder (e.g. restrained eating, disinhibition, emotional eating).
- Psychiatric disorders i.e. schizophrenia, bipolar disease or depression with hospitalization within the last 6 months.
- History or diagnosis of cardiovascular disease including current angina; myocardial infarction; coronary revascularization procedures; stroke (either ischemic or hemorrhagic, including transient ischemic attacks); symptomatic peripheral artery disease that required surgery or was diagnosed with vascular imaging techniques; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (New York Heart Association Class II to IV); myocardiopathy; and history of aortic aneurysm ≥5.5 cm in diameter or aortic aneurysm surgery within the past six months, as diagnosed by a medical doctor.
Show all 17Show fewer
- Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, stable treatment (i.e. no change in treatment, either dose, type of medication or other changes) within the last three months is required.
- History or diagnosis of chronic kidney disease.
- History or diagnosis of liver disease.
- Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption.
- Systemic treatment with glucocorticoids inhalations and creams etc. is allowed
- Cancer: active malignant cancer or history of malignancy within the last five years (with exception of local basal and squamous cell skin cancer).
- Previous bariatric surgery or intention to undergo bariatric surgery within the next 12 months.
- History of extensive small or large bowel resection.
- Known endocrine origin of obesity (except for treated hypothyroidism).
- Current use of prescription medication or use within the previous month that has the potential of affecting body weight such as systemic corticosteroids (excluding inhaled and topical steroids), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgment of the investigator, do not affect body weight or participation in the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the subject has been on a stable dose for at least three months.
- Concurrent therapy with immunosuppressive drugs or cytotoxic agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supervised Online Team-based Resistance Training Versus Unsupervised Self-administered Resistance Training for Elders: a Randomized Intervention Trial
The primary goal of this project is to investigate whether online supervised team-based exercise training is superior for increasing functional strength in elders compared to prescribed self-administered exercise training. Secondarily, the project aims to investigate whether adherence to online supervised team-based exercise training is greater compared to prescribed self-administered training, and if online supervised team-based exercise training can increase quality of life. Finally, this project will generate more knowledge on elderly individuals' approaches and responses to physical exercise through online services. The participants will undergo a 12-week intervention where they will be performing prescribed physical exercise for 5 hours bi-weekly and complete a 3-day dietary registration three times during the study. Participants will be randomized (2:1 ratio) to two groups and will: i) undergo supervised training in groups on an online live meeting platform by trained personnel, or ii) receive prescribed exercises through an online exercise platform but their training will be self-administered and unsupervised.
- Conditions
- Healthy Aging
- Being tested
- Supervised team-based exercise, Unsupervised exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised team-based exerciseBehavioural
The intervention is a 12-week physical exercise program with five training sessions bi-weekly lasting approximately 1 hour each.
Unsupervised exerciseBehavioural
The intervention is a 12-week physical exercise program with five training sessions bi-weekly lasting approximately 1 hour each. First two weeks are supervised, the following 10 weeks are unsupervised.
| Study group | Role | What they receive |
|---|---|---|
| Supervised team-based exercise | Experimental | In this arm, participants will receive guided training by an instructor in teams of 10 on the online platform Zoom. Receives: Behavioral: Supervised team-based exercise |
| Unsupervised exercise | Active comparator | In this arm, participants will perform the training individually with the exercises provided on the platform Exorlive, which is a one-way communication platform. However, the first two weeks (5 training sessions) will be conducted in teams of 10 participants with the presence of an instructor who will introduce, demonstrate, and supervise correct form and technique and ensure understanding of the exercise concept. Receives: Behavioral: Unsupervised exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 5 times sit-to-stand
Physical function, assessed by the '5 times sit-to-stand' (5xsts) test
Measured: Week 0 and week 13
Secondary outcomes (9)
Change in 1 repetition maximum (RM) leg press
Assessed on a leg press machine (Steens Physical)
Measured: Week 0 and week 13
Change in Fat mass
Assessed by bioimpedance analysis
Measured: Week 0 and week 13
Change in Fat-free mass
Assessed by bioimpedance analysis
Measured: Week 0 and week 13
Change in Resting blood pressure
Measured by OMRON M2
Measured: Week 0 and week 13
Change in Quality of life (RAND 36-item health survey)
Assessed by a 36-item short form survey questionnaire. Some questions are scored on a scale from 1-5, others from 1-2, 1-3, or 1-6. The scores are converted to values between 1-100. Some questions are reverse coded such that a high value consistently means a favorable health state.
Measured: Week 0 and week 13
Change in Aerobic fitness
Assessed by the Åstrand-Rhymings step test
Measured: Week 0 and week 13
Change in Balance
Assessed by the Functional Reach Test
Measured: Week 0 and week 13
Adherence to exercise
Assessed by scoring on a Borg Rating of Perceived Exertion scale. Minimum value is 6 corresponding to resting and maximum value is 20 corresponding to maximum exertion. If any score is recorded it is interpreted as the participant having completed the training session.
Measured: At every training from week 1-12
Food records
3-day dietary recall including one weekend day
Measured: Week 1, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start20 Feb 2023
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Studnitz Consulting, Aktiv Hele Livet v. Rasmus Stagsted, Aktiv Hele Livet v. Manuel Thomasen, Moustgaard Consulting
- Responsible party
- Principal investigator, Faidon Magkos, University of Copenhagen
- Investigators
- Faidon Magkos, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885165
- Sponsor's protocol ID
- 514-0396/23-5000
- Acronym
- ONTRAEL
- Status last verified
- Jul 2023
- First submitted
- 6 Mar 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Online Team-based Resistance Training Versus Unsupervised Self-administered Resistance Training for Elders: a Randomized Intervention Trial
- ClinicalTrials.gov ID
- NCT05885165
- Acronym / sponsor ID
- ONTRAEL / 514-0396/23-5000
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Studnitz Consulting, Aktiv Hele Livet v. Rasmus Stagsted, Aktiv Hele Livet v. Manuel Thomasen, Moustgaard Consulting
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 1 Jun 2023 (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.
The primary goal of this project is to investigate whether online supervised team-based exercise training is superior for increasing functional strength in elders compared to prescribed self-administered exercise training. Secondarily, the project aims to investigate whether adherence to online supervised team-based exercise training is greater compared to prescribed self-administered training, and if online supervised team-based exercise training can increase quality of life. Finally, this project will generate more knowledge on elderly individuals' approaches and responses to physical exercise through online services. The participants will undergo a 12-week intervention where they will be performing prescribed physical exercise for 5 hours bi-weekly and complete a 3-day dietary registration three times during the study. Participants will be randomized (2:1 ratio) to two groups and will: i) undergo supervised training in groups on an online live meeting platform by trained personnel, or ii) receive prescribed exercises through an online exercise platform but their training will be self-administered and unsupervised.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised team-based exercise | Experimental | Behavioral: Supervised team-based exerciseIn this arm, participants will receive guided training by an instructor in teams of 10 on the online platform Zoom. |
| Unsupervised exercise | Active comparator | Behavioral: Unsupervised exerciseIn this arm, participants will perform the training individually with the exercises provided on the platform Exorlive, which is a one-way communication platform. However, the first two weeks (5 training sessions) will be conducted in teams of 10 participants with the presence of an instructor who will introduce, demonstrate, and supervise correct form and technique and ensure understanding of the exercise concept. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 65 years.
- Danish reading and listening proficiency.
- Participant is in possession of either a computer, tablet, or smartphone in order to participate in Zoom meetings (supervised team-based group) or training programs via Exorlive (unsupervised group).
- The participant is able to walk independently and without external aids.
Key exclusion criteria (17 listed)
- BMI > 35 kg/m2.
- Participation in other intervention studies or intention to do so, which are likely to affect the present study.
- Known diseases which may affect energy expenditure and/or satiation/satiety/food intake i.e. inflammatory bowel disease, thyroid diseases.
- Current diagnosis of eating disorder (e.g. restrained eating, disinhibition, emotional eating).
- Psychiatric disorders i.e. schizophrenia, bipolar disease or depression with hospitalization within the last 6 months.
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 |
|---|---|---|
| Supervised team-based exerciseThe intervention is a 12-week physical exercise program with five training sessions bi-weekly lasting approximately 1 hour each. | Behavioural | Supervised team-based exercise |
| Unsupervised exerciseThe intervention is a 12-week physical exercise program with five training sessions bi-weekly lasting approximately 1 hour each. First two weeks are supervised, the following 10 weeks are unsupervised. | Behavioural | Unsupervised exercise |
Primary outcome
Change in 5 times sit-to-stand
Time frame: Week 0 and week 13
Physical function, assessed by the '5 times sit-to-stand' (5xsts) test
9 secondary outcomes
Change in 1 repetition maximum (RM) leg press
Time frame: Week 0 and week 13
Change in Fat mass
Time frame: Week 0 and week 13
Change in Fat-free mass
Time frame: Week 0 and week 13
Change in Resting blood pressure
Time frame: Week 0 and week 13
Change in Quality of life (RAND 36-item health survey)
Time frame: Week 0 and week 13
Change in Aerobic fitness
Time frame: Week 0 and week 13
Change in Balance
Time frame: Week 0 and week 13
Adherence to exercise
Time frame: At every training from week 1-12
Food records
Time frame: Week 1, Week 6, and Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy Aging
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
Not yet recruitingObservational study
China Healthy Aging and Fitness Longitudinal Study
Physical Fitness, Aging
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
Skin Aging, Dry Skin
Active, not recruiting
Improving Medication Management in World Trade Center Responders
Polypharmacy
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.
Faidon Magkos, Professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised team-based exercise and Unsupervised exercise in people with Healthy Aging, run by University of Copenhagen at 1 site in Denmark.
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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 7 Jul 2023. 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 Denmark. 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?
Results are not available in the source record.
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?
Change in 5 times sit-to-stand (time frame: Week 0 and week 13). 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 7 Jul 2023.