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

Sponsor
University of Copenhagen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05885165
Collaborator
Studnitz Consulting (Other), Aktiv Hele Livet v. Rasmus Stagsted (Other), Aktiv Hele Livet v. Manuel Thomasen (Other), Moustgaard Consulting (Other)
75
1
2
8.8
8.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Supervised Online Team-based Resistance Training Versus Unsupervised Self-administered Resistance Training for Elders: a Randomized Intervention Trial
Actual Study Start Date :
Feb 20, 2023
Anticipated Primary Completion Date :
Nov 15, 2023
Anticipated Study Completion Date :
Nov 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supervised team-based exercise

In this arm, participants will receive guided training by an instructor in teams of 10 on the online platform Zoom.

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

Active Comparator: Unsupervised exercise

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

Outcome Measures

Primary Outcome Measures

  1. Change in 5 times sit-to-stand [Week 0 and week 13]

    Physical function, assessed by the '5 times sit-to-stand' (5xsts) test

Secondary Outcome Measures

  1. Change in 1 repetition maximum (RM) leg press [Week 0 and week 13]

    Assessed on a leg press machine (Steens Physical)

  2. Change in Fat mass [Week 0 and week 13]

    Assessed by bioimpedance analysis

  3. Change in Fat-free mass [Week 0 and week 13]

    Assessed by bioimpedance analysis

  4. Change in Resting blood pressure [Week 0 and week 13]

    Measured by OMRON M2

  5. Change in Quality of life (QoL) [Week 0 and week 13]

    Assessed by a 36-item short form survey questionnaire

  6. Change in Aerobic fitness [Week 0 and week 13]

    Assessed by the Åstrand-Rhymings step test

  7. Change in Balance [Week 0 and week 13]

    Assessed by the Functional Reach Test

  8. Adherence to exercise [Through study completion, 12 weeks]

    Assessed by scoring of Borg scale

  9. Food records [Week 1, Week 6, and Week 12]

    3-day dietary recall including one weekend day

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Copenhagen Copenhagen Denmark 1958

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Faidon Magkos, Professor, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Faidon Magkos, Professor, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT05885165
Other Study ID Numbers:
  • 514-0396/23-5000
First Posted:
Jun 1, 2023
Last Update Posted:
Jun 1, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 1, 2023