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

NCT05885165 | Unknown

• 1 other identifier: 514-0396/23-5000
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in 1 repetition maximum (RM) leg press

  Week 0 and week 13

• Change in Fat mass

  Week 0 and week 13

• Change in Fat-free mass

  Week 0 and week 13

• Change in Resting blood pressure

  Week 0 and week 13

• Change in Quality of life (RAND 36-item health survey)

  Week 0 and week 13

Study Arms (2)

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.

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.

Behavioral: Unsupervised exercise

Interventions

Supervised team-based exercise BEHAVIORAL

The intervention is a 12-week physical exercise program with five training sessions bi-weekly lasting approximately 1 hour each.

Supervised team-based exercise

Unsupervised exercise BEHAVIORAL

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.

Unsupervised exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Copenhagen: lead
• Studnitz Consulting: collaborator
• Aktiv Hele Livet v. Rasmus Stagsted: collaborator
• Aktiv Hele Livet v. Manuel Thomasen: collaborator
• Moustgaard Consulting: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, 1958, Denmark

Location

Study Officials

• Faidon Magkos, Professor

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: June 1, 2023
• Study Start: February 20, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)