Supervised Online Resistance Training vs Unsupervised Self-administered Resistance Training for Elders

Study Overview
=================
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.

Official Title
-----------------
Supervised Online Team-based Resistance Training Versus Unsupervised Self-administered Resistance Training for Elders: a Randomized Intervention Trial

Conditions
-----------------
Healthy Aging

Intervention / Treatment
-----------------
* Behavioral: Supervised team-based exercise
* Behavioral: Unsupervised exercise


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised team-based exercise<br>In this arm, participants will receive guided training by an instructor in teams of 10 on the online platform Zoom. | Behavioral: Supervised team-based exercise<br>* The intervention is a 12-week physical exercise program with five training sessions bi-weekly lasting approximately 1 hour each.<br>|
| Active Comparator: Unsupervised exercise<br>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. | Behavioral: Unsupervised exercise<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 5 times sit-to-stand | Physical function, assessed by the '5 times sit-to-stand' (5xsts) test | Week 0 and week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 1 repetition maximum (RM) leg press | Assessed on a leg press machine (Steens Physical) | Week 0 and week 13 | 
| Change in Fat mass | Assessed by bioimpedance analysis | Week 0 and week 13 | 
| Change in Fat-free mass | Assessed by bioimpedance analysis | Week 0 and week 13 | 
| Change in Resting blood pressure | Measured by OMRON M2 | 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. | Week 0 and week 13 | 
| Change in Aerobic fitness | Assessed by the Åstrand-Rhymings step test | Week 0 and week 13 | 
| Change in Balance | Assessed by the Functional Reach Test | 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. | At every training from week 1-12 | 
| Food records | 3-day dietary recall including one weekend day | Week 1, Week 6, and Week 12 |