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New lifestyle program aims to boost fitness in older adults at heart risk

NCT ID NCT06122441

Disease control Sponsor: University of Tromso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a program combining exercise, diet advice, and behavioral support can improve fitness and health in adults aged 60-75 who are at high risk for heart disease. Participants in the program receive supervised high-intensity exercise and counseling, while all get activity trackers and standard recommendations. The goal is to see lasting improvements in heart and muscle fitness over 24 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

119 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 60-75 years * BMI ≥ 30 kg/m2 * Elevated CVD-risk (Score 8/12 on the NORRISK 2 model) * Sedentary lifestyle (Score "1" on the Saltin-Grimby Physical Activity Level Scale) Exclusion Criteria: * Presence of dementia diagnosis * Self-reported previous myocardial infarction or stroke, and/or self-reported established cardiovascular disease by presence of coronary stent * Heart failure with ejection fraction \<50% * Electrocardiogram ECG presenting with atrioventricular block grade 2 type 2 or grade 3, or previous myocardial infarction. * Uncontrolled hypertension (systolic blood pressure≥180 mmHg and/or diastolic blood pressure≥110 mmHg unless cleared by a nephrologist) * Chronic obstructive pulmonary disease grade 3 or 4 * Thyroid dysfunction (thyroxine \<7 pmol/L and thyroid-stimulating hormone \>10 mIU/L, and/or thyroxine \>25 pmol/L and thyroid-stimulating hormone \<0.2 mIU/L) * Liver dysfunction (alanine aminotransferase \>210 µmol/L for men, \>135 µmol/L for women, and/or aspartate aminotransferase \>135 µmol/L for men, \>105 µmol/L for women, and/or alkaline phosphatase \>345 µmol/L) * Kidney dysfunction (creatinine \>220 µmol/L), in addition to prognosis of CKD by GFR and Albuminuria KDIGO 2012 algorithm * Severe anemia (hemoglobin \<10g/dL for men, \<8g/dL for women) * Uncontrolled diabetes (glycated hemoglobin ≥86 mmol/mol) * Severe hearing problems * Severe mobility limitations (unable to get up from a sitting or lying position, unable to maintain a crouched position, unable to raise arms above shoulder or head height) * No possession of a smartphone * No access to the Norwegian national identification service (BankID) * Unable to follow the trial regimen for 24 months

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome metabolic syndrome X Motor Activity Muscle Weakness Obesity, Abdominal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abdominal obesity Cardiometabolic syndrome Diet, healthy Lifestyle, healthy Muscle weakness Self efficacy

Contacts and locations

Locations

  • UiT The Arctic University of Norway

    Tromsø, Troms, 9018, Norway

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