Clinical trial NCT05885165: Supervised Online Resistance Training vs Unsupervised Self-administered Resistance Training for Elders
Official title: Supervised Online Team-based Resistance Training Versus Unsupervised Self-administered Resistance Training for Elders: a Randomized Intervention Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Aging
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Studnitz Consulting
name: Aktiv Hele Livet v. Rasmus Stagsted
name: Aktiv Hele Livet v. Manuel Thomasen
name: Moustgaard Consulting
First posted: 2023-06-01
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change in 5 times sit-to-stand
timeFrame: Week 0 and week 13
Secondary outcomes:
measure: Change in 1 repetition maximum (RM) leg press
timeFrame: Week 0 and week 13
measure: Change in Fat mass
timeFrame: Week 0 and week 13
measure: Change in Fat-free mass
timeFrame: Week 0 and week 13
measure: Change in Resting blood pressure
timeFrame: Week 0 and week 13
measure: Change in Quality of life (RAND 36-item health survey)
timeFrame: Week 0 and week 13
measure: Change in Aerobic fitness
timeFrame: Week 0 and week 13
measure: Change in Balance
timeFrame: Week 0 and week 13
measure: Adherence to exercise
timeFrame: At every training from week 1-12
measure: Food records
timeFrame: Week 1, Week 6, and Week 12
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Faidon Magkos, Professor
role: PRINCIPAL_INVESTIGATOR
References: